Showing posts with label deviation. Show all posts
Showing posts with label deviation. Show all posts

Monday, May 13, 2013

( Scientific Deviation Investigator/Technical Writer ) ( Chemist ) ( Entry Level Microbiologist ) ( Scientist ) ( Senior Chemist ) ( Pharmaceutical Sales Representative - Littleton, CO ) ( Production Technition I ) ( Document Control Specialist ) ( Estimator for Diesel Power Equipment ) ( I & E Planner ) ( Project Manager ) ( Construction Superintendent ) ( Construction/Maintenance ) ( Roofer ) ( CDL Driver )


Scientific Deviation Investigator/Technical Writer

Details: Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Scientific Writer  in a prestigious Fortune 500® pharmaceutical company located in Wilson, NC. By working with Kelly in this role, you would be eligible for:- A competitive hourly pay rate with weekly checks - Access to newly expanded Medical Plan options- Online continuing education via the Kelly Learning Center- Several employee discounts- And more! This is a 6 month temporary position at 40 hours per week. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. If you have questions about the position, you may contact the recruiter recruiting for this position ( or call 732-246-1396 x 203).   Job Title Deviation Investigator The deviation owner will lead the investigation of deviations that occur in operations and are responsible for authoring the investigation. Partners with quality assurance, quality control, operations, engineering, maintenance, calibration, safety and supplier quality management to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions. Interacts will all levels of staff and provides status updates as well as present the strategy for closure of deviations. Manage several investigations at a time.RESPONSIBILITIES  Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures. Determine appropriate preventative actions to prevent reoccurrence of the deviation.  Author deviations.Conduct personnel interviews to determine root cause of the deviation.  Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate. Set up and run meetings with cross functional teams. Close deviations in a timely manner to meet business and compliance needs. Work with minimal supervision to drive deviations to closure. Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports. Work with the Technical Services, Subject Matter Experts and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective actions, complete trending analysis, and recommend product disposition. Present and defend investigations during regulatory inspections, as required. SkillsStrong communication, project management and leadership skills. Must have a thorough understanding of the pharmaceutical/biotech manufacturing process and equipment, preferably solid oral dosage, and current Good Manufacturing Practices cGMPs . Must have good analysis, troubleshooting, and investigation skills. Must be able to put complex thoughts and issues into writing in such a manner than an educated, but uninformed reader can understand and make decisions based on the written investigation report. Must be able to interact with, and influence others at various levels in multiple departments.Must be detail oriented, able to excel under pressure as well as demonstrate flexibility, and promptness in dealing with changes, and unanticipated challenges in a matrixed environment. Must be able to evaluate true root cause using analysis tools. Must have strong computer skills in applications such as Word, Excel, PowerPoint, Trackwise and other data reporting and analysis tools. Excellent verbal/written communication and presentation skills. Ability to act independently and take initiative. Must be effective at managing time and priorities and display a sense of urgency. Requires multi-tasking / ability to lead multiple projects at one time. Demonstrated ability of influencing others at all levels to drive results. Requires leadership / management of all aspects of the deviations.  Education Bachelors Degree with 5 years of manufacturing experience or a minimum of 8 years manufacturing experience and equivalent training. Minimum of 3 years experience in a regulated environment such as medical devices, pharmaceuticals or biotech industry.    About Kelly Services®Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.  Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.  Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.  Revenue in 2012 was $5.5 billion.  Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.Connect with us on

Chemist

Details: Title:  Analytical ChemistLocation: Duluth, GADuration: 6-12 months Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer an opportunity to work as an Analytical Chemist in a Fortune 500® pharmaceutical corporation located in Duluth, GA In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:-      Competitive pay-      Access to newly expanded medical plan options-      Paid holidays-      Year-end bonus program-      Portable 401(k) plans-      Recognition and incentive programs-      Access to continuing education via the Kelly Learning Center This is a 12 month temporary position at 40 hours per week.  Description:  •         Perform and support the transfer and implementation of analytical methods and testing of raw/ in process materials for LightStream3 at Alcon John's Creek Manufacturing facility.•         Perform and support analytical method transfers and method validations activities.•         Accurately assess the purity, potency, efficacy, and other performance characteristics of the materials in the analytical chemistry laboratory for the purpose of supporting both manufacturing and quality assurance in the production, release, and monitoring of established product lines.•         Actively work in a team environment and participate in natural work groups to support product implementation and increase productivity.    Skills:  •         Minimum 5+ years in a cGMP regulated industry with knowledge of FDA & Quality System requirements.•         Must have analytical method validation and transfer experience.•         Must have strong technical knowledge and experience in the use of GC, LC, UV-VIS, FTIR, titrations, pipetting and dilutions, etc.•         Must be a highly motivated, goal oriented achiever with ability to prioritize and organize own work semi-independently.•         Excellent oral and written communication skills.•         Excellent level of written and spoken English Required.•         Proficiency in MS Word and MS Excel. Education: •         BS in Chemistry or related field  Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.  We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com. About Kelly Services®Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.  Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.  Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.  Revenue in 2012 was $5.5 billion.  Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.Connect with us on

Entry Level Microbiologist

Details: Kelly Scientific Resources currently has a 4 month long contract opportunity available as an entry level Microbiologist. Job Summary: •         Performs laboratory assays that demand a professional application of the principles, theories, and techniques of cell culture and media preparation. •         Position Responsibilities: Performs assays and proper documentation. •         Organizes laboratory supplies, media and reagent shipments. •         Performs daily monitoring and cleaning of equipment and applicable facilities. Prepares documentation of in house media and reagents. •         Understands and performs the following laboratory techniques: aseptic technique, micro biology, light and fluorescent microscopy and reagent preparation. Education Required: Bachelor’s Degree in Microbiology or equivalent.About Kelly Services®Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.  Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.  Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.  Revenue in 2012 was $5.5 billion.  Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.Connect with us on

Scientist

Details: Research ScientistWho we are… Since 1985, The Davis Companies has provided career opportunities in a variety of industries. We deliver innovative career options and pride ourselves on offering a consultative rather than transactional approach. Our perpetual goal is to fulfill the career needs of our candidates and the staffing needs of our clients with a simplified hiring process and enhanced quality of service. What we're looking for… We are currently seeking a Scientist to work in our client's Cambridge office with an organization that will hopefully someday… save the world! Fantastic opportunity to work in a non-profit enterprise that helps save lives by creating low-cost diagnostics for people in developing nations with little to no access to quality healthcare. It doesn't get much better than that.We need a highly motivated Scientist to assist in the development of a non-invasive and rapid point-of-care diagnostic for markers of vaccinations.For this position, we ask that candidates have the following experience:Proven track record of immunoassay development, preferably in the lateral flow or other solid-matrix formats5-10 years' experience in a Scientist roleExperienced with ELISAExperienced with biological samples, including blood and preferably saliva What you will be doing…Optimization of device performance to achieve desired sensitivity using a design of experiment methodology (DOE)Designing and manufacturing of paper-based devicesCoordinating sample collection, standardization and storage Please note - this is a 2-3 month contract position with some possibility to be extended Flexible hours! Must work core hours of Monday-Friday 9am-4pm, but free to work any 8 hour schedule around that What we have to offer… In this position, the ????????Scientist will be a vital part of our client's future success. In addition, benefits include paid time off, health and dental insurance, direct deposit, a 401(k) option and disability insurance among others. Still reading? Thought so! Apply now and let us know what makes you great and how you can accelerate our client's growth. Assuming you are as great as you say you are and that your background aligns with the position, you will be hearing from us in the very near future.…don't wait!! APPLY NOW!!!

Senior Chemist

Details: Consider joining Lancaster Laboratories where people are the most important element in our chemistry.  Celebrating 50 years of service, Eurofins Lancaster Laboratories is a leading contract lab providing testing and research services in the environmental, pharmaceutical and biopharmaceutical sciences to clients worldwide. Eurofins Lancaster Laboratories, a nationally recognized laboratory, is searching for a Senior Chemist to support our Professional Scientific Staffing group at one of our client sites in Winston-Salem, NC. Chemist responsibilities include, but are not limited to, the following: •Perform routine and special analyses, utilizing GC/GCMS and other ancillary equipment •Provide support to method development/validation utilizing GC/GCMS and other ancillary equipment •Read, understand, and interpret diverse analytical procedures presented in a variety of written styles •Perform instrument calibration and instrument troubleshooting •Review and verify data •Recognize errors, identify root causes, recommend process improvements •Revise or write SOP’s as needed •Work independently and efficiently •Document work clearly and perform tests accurately •Communicate effectively with client staff members The ideal candidate would possess: •Experience in a cGMP and ISO 17025 environment •Strong computer, scientific, and organizational skills •Excellent communication (oral and written) and attention to detail •Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude •Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Basic Minimum Qualifications: •Bachelors degree in chemistry, biology, or other related degree concentration, or equivalent directly-related experience (2 years of directly related industry experience is equivalent to1 full-time year of college in related major) •5 years GC and/or GCMS experience •Authorization to work in the United States indefinitely without restriction or sponsorship   Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed.  Candidates currently living within a commutable distance of Winston-Salem are encouraged to apply.   As a Eurofins Lancaster Labs employee, you will become part of a company that has received national recognition as a great place to work.  We offer excellent full-time benefits including: comprehensive cafeteria plan medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.

Pharmaceutical Sales Representative - Littleton, CO

Details: Pharmaceutical Sales Representative Publicis Touchpoint Solutions seeks passionate and experienced Pharmaceutical Sales Representatives to join our team. We have partnered with a leading pharmaceutical company with a vast portfolio of medicines across a broad range of therapeutic areas.  Requirements  Knowledge / Skills / Experience § BA/BS degree required § 2+ years of pharmaceutical sales experience § Must have and maintain a valid driver’s license § Customer focused § Demonstrated team work/collaboration § Good organizational, planning skills; disciplined § Able to provide documented sales success § Self motivated / performance accountability § Excellent communication skills § Good judgment § Computer proficient § Working knowledge of pharmaceutical industry   Company Overview Publicis Touchpoint Solutions design and implement customized healthcare sales, service, and communication teams. We listen to our Clients, create cross channel solutions and achieve their goals. Website: www.TouchpointSolutions.com Twitter: http://twitter.com/pTouchpoint LinkedIn: http://linkd.in/pTouchpoint  Publicis Touchpoint Solutions offers competitive compensation, a bonus plan, 401-K benefits, comprehensive benefits package, car/travel allowance, and the opportunity to grow with the nation’s leader in healthcare sales. If you have a proven record of sales success and the desire to have a positive impact in the healthcare field, we want to hear from you. For immediate consideration, please apply online at www.touchpointsolutions.com . Publicis Touchpoint Solutions is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however; only qualified candidates will be contacted

Production Technition I

Details: Production Technician8+ month Contract positionDuties:  •         Carry out standard operating procedures involving materials measurement, materials handling and inventory control, equipment operation and record keeping necessary to manufacture product batches as instructed. •         Record keeping includes but is not limited to Batch Data Records, notebooks, customer reports and work order documents. •         Understanding that Safety is paramount•         Maintain accurate inventory of products and inventory records using the Materials Resource Planning tools i.e. issuing materials to work orders, completing products to inventory, kitting, closing, transfers, returns, expensing of raw materials, WIP and finished product. •         Complete production and quality analysis of reagents, components and finished products in accordance with the Production Schedule. •         Communicate manufacturing problems to Manufacturing management and the team and assist in identifying variables and offering resolutions.•         Keep Manufacturing Supervisors and team members informed on the status of assigned production processes.•         Has good Math skills with adding, subtracting and basic math problems •         Basic understanding of Excel and Word•         Complete all batch data records completely, according clients Quality Systems standards as required.•         May perform other related duties as required and/or assigned. •         This position largely interacts with equivalent levels of personnel in the manufacturing area. •         Good oral and written communication skills are required to communicate work status and problems. •         Effectiveness in this role requires a functional knowledge of applicable clients manufacturing process and Standard Operating Procedures and the ability to consistently and accurately follow procedures. •         The job encounters semi-routine work situations of limited scope and complexity where ability to recognize deviation from accepted practice is required. •         Accuracy is required in performing all functions of this position; errors in work could cause delays in schedules.   Education:•         High school diploma required; technical training in manufacturing preferred.  About Kelly Services®Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.  Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.  Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.  Revenue in 2012 was $5.5 billion.  Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.Connect with us on

Document Control Specialist

Details: Kelly Engineering Resources is currently seeking a Document Specialist for a contract to hire opportunity with a great company in the Indianapolis, IN area.The person in this job is responsible for coordinating the flow of paperwork and data within the manufacturing department and between support departments in order to meet the production and product release schedules.  The Document Specialist/ Manufacturing Administrator ensures that all documents are current and provided in a timely manner in order to maintain the appropriate production levels and ensure customer commitments are met.   Major Position Activities & Responsibilities: Provide administrative support for the Manufacturing department and associated groups.Prepare controlled document revisions upon request by Manufacturing personnel and administer the revisions through the approval process.Administer the department change control process.Write, revise and create batch record and procedures as required.Coordinate and track batch record flow through the manufacturing department.   Compile department metrics in Excel spreadsheets and prepare daily, weekly, and monthly status reports.Represent manufacturing department on cross-function teams.Provide administrative support to other departments as needed.  Performs special projects and other duties as assigned.As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes.  The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.Background Qualifications:Associates degree or four years work experience involving computerized document revision and control systems, metrics coordination, and batch record processing. Background with technical writing a strong plus.Minimum of one year experience in a regulated GMP environment (Pharmaceutical/Biotech/Diagnostics) Must have excellent computer skills. Highly proficient in MS Word and Excel. Some experience with inventory management systems. Must be well organized, detail and multi-task orientedWorks well under pressure and able to prioritize workloads. Works well in a team environment Please click the Apply Now button to be considered for this great Document Specialist opportunity!About Kelly Services®Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.  Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.  Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.  Revenue in 2012 was $5.5 billion.  Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.Connect with us on

Estimator for Diesel Power Equipment

Details: DIESEL GENERATOR EQUIPMENT ESTIMATORThe position provides entry level opportunity in strong niche market supporting the emergency stand-by power generation industry.  Best candidate will have military experience/exposure to the maintenance or procurement of diesel generators in the field.  Also the ability to interpret and understand written specifications, electrical diagrams, building code requirements, sound control, with metal manufacturing and large product transportation logistics being a plus. Other qualities would include being able to provide clear concise communication to customers and internal departments to insure accuracy, profitability and end user satisfaction. Provide cost effective solutions through products and services offered to build lasting relationships with individuals in existing distribution network.

I & E Planner

Details: I & E MAINTENANCE PLANNERThe I & E Maintenance Planner function is the hub from which all I&E maintenance activity that can be planned is coordinated. This position is responsible for the preparation and delivery of effective work procedures and work schedules for electrical, instrumentation and electronics technicians. Principle Accountabilities:1. Improves workforce productivity and quality by anticipating and eliminating potential delays through planning and coordination of labor, parts and materials, and equipment access. Provide long-range and short-range planning of I & E work.Develop high quality work procedures that include task/step sequences, required skill sets, crew sizes, labor hours, materials, parts, tools, etc.2. Receives and plans all requests for I & E maintenance work within job safety assessment and procurement requirements to ensure that conditions are fulfilled to schedule the work order for execution.Examines the job to be performed. Determines the best way to accomplish the work in consultation with the Requestor and/or Maintenance team.Determines the activities, sequence, procedures, parts, services, manpower, tools and/or material lists are needed.Determines the feasibility of the work order.Determines the availability of resources. Identifies and plans manpower workforce (inside and services) required for the execution of the activity(ies). Enters a requisition for services, if applicable.Determines if the MOC process needs to be triggered.Determines the appropriate SOP to be followed, if applicable.Determines the availability of parts and materials. Enters a requisition, if needed.Reviews the warranty on assets for coverages and limits.Determines the availability of tools. Schedules tools and/or enters a requisition for tools needed.Assembles the planned job in preparation for scheduling and reviews with the Maintenance Manager.Estimates the total maintenance cost.Receives approval for maintenance costs on assets when estimated maintenance costs exceed a pre-determined limit.

Project Manager

Details: Affiliated Western Inc is a General Contractor that has worked solely for Federal Government Agencies since 1994. We are looking for another project manager with past experience managing projects at either VA Hospitals, Department of Defense sites or other Federal Government agencies. We have an immediate opening to jump in and take over several projects that are in various stages of completion.  Our project managers help the estimating department determine a work plan for each bid, write and negotiate subcontracts, facilitate the entire submittal process, develop a cost loaded project schedule, create a project budgets, manage superintendents, safety and QC personnel, invoice the owner, approve subcontractor draws and manage the closeout process. Our projects are anywhere in the United States and will require occasional travel to the job sites but will not require any long term stays.  If you can start immediately and have the direct experience of managing at Federal Government sites, we look forward to speaking with you.  This position will office out of our Fort Worth location.

Construction Superintendent

Details: CONSTRUCTION SUPERINTENDENT (Water Treatment) Dugan & Meyers, a Cincinnati based firm, is currently accepting applications for the position of Superintendent for treatment plant construction.  The position is in the Greater Columbus area and the current assignment and future assignments may require some travel.  The duties of treatment plant superintendent include planning, coordinating and supervising all aspects of day to day treatment plant construction including self-performance of earthwork, concrete, yard and interior piping, process equipment, metals and supervision of all subcontracted work.  Primary responsibilities also include maintaining high quality work, meeting budget and schedule expectations, all in a no lost time and safe work environment.

Construction/Maintenance

Details: We are a mobile home rental community in Anaheim looking for an experienced Construction/Maintenance person with customer service skills. This position is responsible for maintenance and repairs to all company owned mobilehomes (both vacant and occupied) and common area community buildings (clubhouse, laundry, restrooms) as well as the remodeling of homes and general maintenance for the overall appearance of the park. This is a FT position with benefits. $11-$14 per hour DOE

Roofer

Details: Tremco Incorporated is seeking experienced roofersl to perform a variety of maintenance, repairs and other roofing-related services in Bellevue, WA. The qualified candidate will have a minimum of 5 years of  commercial roofing experience, and be thoroughly familiar with built-up, EPDM, PVC and other forms of low-slope roofing systems. A valid drivers license and reliable transportation required. Offering competitive wages, mileage compensation, the opportunity for benefits (401K, healthcare, earned vacation time) and advancement.

CDL Driver

Details: ABOUT USAmerican Cable & Telephone (ACT) helps Cable companies raise the bar in customer service. We provide reliable, professional installation & repair services for Video, High-Speed Internet, and Digital Telephone products. ACT utilizes technology by creating processes that help support the professional work of our technicians.ACT is currently seeking a Class A CDL Truck Driver to join our growing Construction team.  We currently have a need to have a Truck Driver assist the construction team in the West Suburbs of Chicago with trips to Central Illinois as well.  Your job would be to deliver in a timely fashion the construction equipment needed for that specific job (Truck + flatbed and truck + trailer combinations).Compensation will start on an hourly basis based on experience with the possibility of the position becoming a weekly salaried position. Gas card provided for company travel Company phone Health, Dental, and Life insurance offered Paychecks are cut weeklyCall (630) 270-3399 to schedule an interview or submit your resume via Career BuilderRESPONSIBILITIES Checking vehicles to ensure that mechanical, safety, and emergency equipment is in good working order Maneuvering trucks into loading or unloading positions, following signals from loading crew and checking that vehicle and loading equipment are properly positioned Collecting delivery instructions from appropriate sources, verifying instructions and routes Maintaining logs of working hours or of vehicle service or repair status, following applicable state and federal regulations Reporting vehicle defects, accidents, traffic violations, or damage to the vehicles