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Hours Full-time, Part-time
Location Franklin, MA
Franklin, Massachusetts

About this job

We have a full-time/part-time opening for a Quality Control Analyst.

Must be able to work various shifts per week.

Requirements

Manpower is currently recruiting in Milford, MA. We are looking for a Quality Control Analyst. Summary The Quality Control Analyst in Microbiology is responsible for performing QC tests and processes in support of the site manufacturing of an FDA-approved drug. Position schedule is Monday-Friday, 8:00 am - 4:30 pm, and may require participation in the Quality Control team's weekend coverage rotation. Specific tasks: * In according with test method SOPs, perform environmental monitoring of clean rooms and water system sampling and testing, as well as in-process, release and stability sample testing * Perform microbiological analyses including bioburden, endotoxin, TOC, conductivity, nitrates, appearance testing, media performance, growth promotion and microbial identifications. * Investigate, assess, and troubleshoot assay and/or equipment problems. * Notify QC management immediately when a deviation, an aberrant result, or an OOT/OOS result is discovered. Participate in authoring investigation report as required. * Participate in method qualifications, validations, and transfers as required. * Maintain sample tracking and integrity at all times until analyses are reviewed. * Perform general lab maintenance. Order supplies as needed, store materials as indicated and discard expired materials as per manufacturer or test method recommendations. * May prepare and complete change control requests using electronic systems such as Trackwise. * Support investigations of deviations and prepare exception documents, utilizing problem solving tools as needed. * Maintain data integrity and ensure compliance with relevant regulations such as the clients SOPs, FDA, CGMP, Eu. Ph.,GLP, GDP, and QSR * Support principles such as 5S throughout daily work activities. * Ensure personal training requirements are met and that training records are current. Education and Experience Bachelors degree in Microbiology, Biology or a related scientific discipline with minimum skills required to include aseptic technique, microbial identifications, strong written and verbal language skills to effectively read and write SOP's and related lab reports and communicate with personnel at all levels in the organization. Preferred experience includes: GMP lab experience in a pharmaceutical or biotech Quality Control in a GMP environment with specific experience in microbiological testing and sampling, and an understanding of quality systems including change control, deviations and CAPAs. If you are interested in this role, please directly apply. For additional details on this role contact: Abbie Hoffman Email: abigail.hoffman@manpowergroup.com