Quality Assurance Batch Release Coordinator - 10:00am to 7:00pm
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POST DATE 8/17/2016
END DATE 11/3/2016
VWR International, Inc
JOB DESCRIPTIONPerforming documentation review of all Production (e.g., Manufacturing) and Quality Control (QC) records as part of the approval process of batch release. Assisting in internal investigations (i.e., events) and external investigations (i.e., complaints) on any AMRESCO products, including investigations that require material quarantines. Prevent distribution of non-conforming products to customer. Assure compliance with all applicable standards and regulations (e.g., ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, and EXCiPACT).
* Coordinates, reviews, and releases all QC Incoming, Manufactured, Reassay, LIMS request, Analytical Testing Request, and END-ID documentation. Ensures completeness and accuracy of all documentation. Verifies adherence to processes.
* Verifies that Out Of Specification (OOS) activities have been completed.
* Verifies and understands OOS investigation results to ensure compliance for product release.
* Releases or rejects materials based on the batch record(s) and testing result(s).
* Understands all QC testing capabilities, as well as test methods, to ensure compliance with required specifications.
* Complete appropriate paperwork, such as analytical requests, Device History Record (DHR) checklists, and work requests.
* Oversees aspects of Quality Assurance (QA) including; but not limited to, establishing metrics, applying industry standards, and developing new tools / processes to ensure correct procedures / testing results.
* Serves as an interface between QC and QA to ensure proper documentation is provided.
* Assists with reviewing and investigating quarantined material, and makes recommendations for process improvements, if applicable.
* Reviews documentation submitted by Manufacturing and QC to ensure quality standards / procedures for key processes and customer requirements were met.
* Assists with customer complaints via the Complaint Investigation team to formulate proper results and necessary testing that is needed in order to complete proper documentation and closure of complaint.
* Collects and reviews trending of quality metrics on a weekly, monthly, and quarterly basis.
* Identifies trends and provides recommendations for corrective actions (e.g., CAPAs) to eliminate documentation / departmental errors.
* Identifies compliance gaps, and develops, writes, revises, and reviews procedures, when needed. Recommends areas for workflow efficiency and improved resource management.
* Collaborates with other departments and conforms to the established company policies, procedures, objectives, and goals regarding QA and QC.
* Utilizes the equipment and maintenance / verification procedures of the following instrument types: pH meter, osmometer, conductivity meter, Densito, viscometer, EM quant test strip,
* Millipore yeast and mold, heterotrophic bacteria plate counter, melting point apparatus, sieve tester, spectrophotometer, refractometer, polarimeter, hellige tester, oven, incubator, desiccant, titrator, gel box.
* Ensures all required documentation is included with the QC protocol submitted for review.
* Ensures all supporting analytical data is present, and all documentation is complete before batch approval and release / closure.
* Observes all prescribed safety rules and regulations, and maintains work area in a neat and orderly condition.
* Performs other duties as assigned.
Experience & Skills:
* Must be able to balance multiple tasks and prioritize efficiently
* Ability to work with and apply mathematical concepts such as fractions, percentages, ratios, and proportions to practical situations
* Knowledge of ISO or FDA regulations such as ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, and EXCiPACT
* Knowledge of US, EU, and ICH cGMP regulations and guidelines, and QA best practices is a plus
* Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages
* Knowledge and experience utilizing a laboratory information management system (LIMS) and an Enterprise Resource Planning (ERP) system is preferred
* Excellent attention to detail, follow through, and organizational skills with an ability to advocate a quality environment
* Excellent verbal, written, and interpersonal communication skills
* Bachelor s or Technical degree in Life Sciences or related scientific discipline; a Chemistry degree is preferred. A minimum of 4 years of directly applicable work experience will be considered in lieu of a degree.
* At least 1 year experience in a regulated industry is required.
* At least 1-3 years of Good Manufacturing Practices (GMPs) experience in the medical device, biotech, or pharmaceutical industry is preferred.
* At least 1 year of experience in a laboratory is required
* At least 1-3 years of laboratory experience in the medical device, biotech, or pharmaceutical industry is preferred.
Environmental Working Conditions & Physical Effort:
Typically works in an office environment with adequate lighting and ventilation, and a normal range of temperature and noise level.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis.
Minimal physical effort is required. Work is mostly sedentary, but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 25 lbs.
While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment is usually moderate
VWR (NASDAQ: VWR), headquartered in Radnor, Pennsylvania, is the leading, global, independent provider of product and service solutions to laboratory and production customers. With sales in excess of $4.3 billion in 2015, VWR enables science for customers in the pharmaceutical, biotechnology, industrial, education, government and healthcare industries. With more than 160 years of experience, VWR has cultivated a value proposition delivering product choice, operational excellence and differentiated services to improve our customers' productivity from research to production. VWR's differentiated services provide innovative, flexible and customized solutions from scientific research services to custom-manufactured chemical blends. Our dedicated team of more than 9,300 associates is focused on supporting scientists, medical professionals and production engineers to achieve their goals.
VWR s differentiated services provide innovative, flexible and customized solutions from scientific research services to custom-manufactured chemical blends. Our dedicated team of more than 8,500 associates is focused on supporting scientists, medical professionals and production engineers to achieve their goals.
In addition to being a part of a global organization, VWR offers its associates competitive salaries and a wide range of benefits designed to help them stay healthy, plan for the future, prepare for the unexpected and balance the demands of work and home. VWR offers an outstanding benefits package that includes a 401(k) plan with a generous company matching contribution; medical, dental and life insurance; short- and long-term disability; EAP (employee assistance program); flexible spending account (FSA); holiday/vacation time; work/life balance programs; and education assistance.
At VWR, our associates are the framework of who we are and how we succeed.
We value their accomplishments and offer long-lasting opportunities for growth and success. As a result, a substantial percentage of our associates have 10-, 20- and 30-year histories