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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

Proclinical is currently recruiting for a QC Analyst with a leading biopharmaceutical company located in Boston, MA. As the QC Analyst, you will plan and support execution of internal as well as outsourced analytical testing, analytical qualifications, and stability studies of exosomes, biological molecules, oligonucleotides, small molecules, and drug products.

Job Responsibilities:

Drafting stability protocols, trending/reviewing stability data, writing stability reports
Performs routine and stability testing in the laboratory.
Review of release, stability, and characterization data, including technical review of change control documentation and reports, deviations, and OOS.
Assist in outsourcing of release and stability test methods, including test method transfer, assay qualification and troubleshooting.
Collaborate with Analytical Development on identifying, developing, and qualifying test methods to support phase-appropriate product release and stability testing.
Work collaboratively with Upstream PD, Downstream PD, Analytics, and Research groups to develop an increased depth of knowledge of processes and identify improvement opportunities.
Resolve technical problems through scientific understanding, options assessment, and application of innovative solutions.
Generate complete, accurate, and concise laboratory documentation.
At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.

Skills and Requirements:

BS and/or MS degree in biochemistry, cell biology and/or molecular biology discipline.
At least 3 years work experience in a GMP environment.
Background in QC Stability Studies.
Background in methodologies supporting both biologics and small molecules.
Direct experience in authoring and review of SOPs, assay qualification protocols and reports.
Strong knowledge of cGMP/ICH/FDA/EU regulations.
Work with minimal supervision, demonstrated ability to troubleshoot, quickly design and execute thoughtful experiments leading to innovative solutions.
Strong work ethic and strives to learn new things, and capable of working independently and in a collaborative environment.
Excellent communication, project management, and presentation skills (oral and written);
Proven track record of being personable, energetic, responsive, empowering, inclusive, action-oriented, accountable, and an effective communicator.

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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