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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 Senior Quality Assurance Specialist with a pharmaceutical company located in Burlington, MA.

Job Responsibilities:

Responsible for working cross-functionally with Manufacturing, Process Engineering, Facilities, Inspection, and Project Management on Quality Assurance (QA) activities such as the following:

Quality oversight for validation (review of IQ, OQ & PQ packages)
Compliance to Validation Master Plan requirements
Manufacturing Quality Oversight (batch record review, quality approver for manufacturing deviations)
Quality Impact Assessment for Manufacturing and validation related Deviations, Change Controls, and CAPA
Driving Quality Metrics
Product Disposition

Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP's and quality system to ensure real-time compliance
Represent quality assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented

Skills and Requirements:

Bachelor's Degree in a life science field; an alternate field of study may be considered in combination with significant Aseptic Manufacturing industry experience
6+ years of experience in Quality Assurance supporting manufacturing in Pharmaceutical, Biotechnology or Medical Device industry
Previous experience supporting on-the-floor activities for a production facility
Strong facilitation and problem-solving skills
Excellent written and verbal communication and presentation skills. Comfortable presenting information to management & peers
Comfortable working independently in combination with individuals in other departments across the organization
Strong working knowledge of PDA, FDA (21 CFR Part 210, 211, 600), EMA (Eudralex Volume 4), ICH, ISPE, USP/EP monographs, and GAMP 5 guidance
Proficient in Microsoft Office and TrackWise

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.

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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