Quality Control Specialist job in Lexington, USA

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Job type: Permanent

Discipline: Senior/Director & VP, Good Manufacturing Practice (GMP), Good Pharmacovigilance Practice (GVP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Quality Control Specialist with a pharmaceutical company located in Lexington, MA.

Job Responsibilities:

Writes and develops method validation protocols, reports and test methods.
Performs method validation protocol activities in the laboratory.
Review of method validation protocol data.
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 6 years work experience in a GMP environment;
Background in analytical method development, analytical support of manufacturing campaigns, quality control, and method transfer;
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, 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 Bri Copeland at 267-297-3280.

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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