QC Analyst

We at Global Life Science Hub are recruiting on behalf of an innovative biotech company that is experiencing rapid growth following FDA approvals and commercial expansion. This role is integral to ensuring the highest quality standards for biotechnology products designed for clinical and commercial human use.

Position: QC Analyst III
Industry: Biotechnology

Key Responsibilities: As a QC Analyst III, you will play a pivotal role in the Quality Control department, conducting essential testing to guarantee product quality and safety. Your responsibilities will include:

• Performing analytical and microbiological testing in compliance with current Good Manufacturing Practices (cGMP)
• Conducting in-process and release testing, such as pH, conductivity, spectrophotometry, and environmental monitoring
• Preparing and reviewing technical documents and SOPs
• Maintaining lab...

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...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

Editas is seeking a Quality Control Analyst to 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 in conducting activities...

• Review daily instrument calibration and verifications; and review of logbooks
• Review testing with other analysts and supervisor
• Perform calibration and system suitability using approved Methods
• Problem solve with colleagues regarding OOS results, discuss additional testing, operation of equipment, meeting to share ideas. CAPA responsibility
• Review NCRs prior to submission to Lab Manager, check calculations, possible cause with review of batch records.
• Assist with quality and environmental health and safety audits
• Perform analytical testing using HPLC, GC, ICP-OES, UV-VIS, Karl Fischer, etc.
• Compliance to Data Integrity requirements
• Assist with investigation of quality issues such Out of Specification (OOS), Out of Trends (OOT), etc.
• Train on and support the chemical hygiene program for the laboratory
• Execute testing methods, protocols and other work instructions
• Assist in...

• Support process validation/qualification, equipment/instrument calibration and verifications, including the review of logbooks, instruments, media, etc.
• Review testing with R&D, schedule workload for samples from mfg and pdn
• Problem solving with colleagues regarding OOS results, discuss additional testing, operation of equipment, meeting to share ideas. CAPA responsibility
• Assist in drafting NCRs prior to submission to Lab Manager, check calculations, possible cause with review of batch records
• Assist the Microbiologist/Supervisor in the review of workload priority and staffing requirements with Manager to assure organization priorities are met and communicate priority releases
• Assist with quality and environmental health and safety audits
• Maintain experience with Incubators, Laminar Hoods, Bio Safety Cabinets, Autoclaves, Simple and Compound Microscopes, Colony Counter, DI Water Units, Media, Cultures, Standards,...