Senior Quality Assurance Specialist
Proclinical is currently recruiting for a Senior Quality Assurance Specialist with a pharmaceutical company located in Burlington, MA.
- 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.