Senior QC Analyst, Raw Materials and Testing

Senior QC Analyst, Raw Materials and Testing (Editas Medicine, Inc.; Cambridge, Massachusetts): The Senior QC Analyst, Raw Materials and Testing will join the Quality team and play a significant role in the support of our product pipeline. Reporting to the QC Manager, Internal Operations, this position will be responsible for Raw Materials release testing as well as in process and final product release testing in Cambridge, MA. This position will be responsible for a variety of analytical testing including, but not limited to HPLC, Bioassay, PCR, Gel Electrophoresis, and compendial testing. Responsibilities:  Oversee sampling and storage of QC samples and maintain retain inventory; Maintain laboratory equipment/instrumentation and systems to ensure compliance; Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures, such as Protein Assays, Q-PCR, pH, and Osmolality; Utilize aseptic technique and work with Cell Maintenance, Cell Passaging, Cell Counting, Cell Culture, and live viruses; Generate protocol and reports, as required; Perform sample management such as receipt, inventory, and tracking; Coordinate shipment of samples to contract testing laboratories, as required; Track trend data and aid in compilation of trend reports; Complete documentation in accordance with current Good Manufacturing Practices (cGMP); Maintain QC lab and related systems to ensure compliance with industry standards; Responsible for change controls, OOS, and deviations as related to QC raw materials, including investigations, as required; Work in compliance with cGMPs, effectively demonstrating an understanding of cGMPs and how it applies to specific responsibilities; Communicate inter-departmentally and with outside contacts to solve technical issues; Exercise sound judgement and decision making when problem solving; and Revise Quality System procedures.

Requirements

Minimum requirements: Master's degree or foreign equivalent in biology, chemistry, or related discipline PLUS 3 years of relevant industry experience.

Must Have: Demonstrated hands-on experience and demonstrated organizational skills in a regulated analytical/QC environment; Demonstrated working knowledge of current Good Laboratory Practices (GLP - 21 CFR Part58), Good Manufacturing Practices (cGMP - 21 CFR Part 210/211), Electronic Records Practices, and Electronic Signatures Practices (21 CFR Part 11); Demonstrated proficiency in the use of MS Office tools, and electronic document and training systems; Demonstrated experience with management and implementation of e-Quality Systems.(Unless otherwise indicated, employer is seeking ability in skills listed above with no specific amount of years of experience required. All experience can be gained concurrently.)

Apply online at https://www.editasmedicine.com/careers/ or send resume to: Abbie McGourty [email protected]. Ref: 00059973. An EOE.

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