Quality Assurance Specialist
Bedford, MA
Job Type: Contract | Recruiter: Hillary Bergstrom | Phone: 603-772-2700
Location: Greater Boston, MA (Onsite)
Length: 6+ months
Job Description:
Our client is seeking a highly motivated QA Specialist to support quality operations. This individual will play a critical role in maintaining and enhancing quality systems across QA, QC, and Technical Operations. This role requires an experienced quality professional with strong technical and regulatory knowledge, a collaborative mindset, and a proactive approach to ensuring compliance and continuous improvement.
Essential Duties and Responsibilities (but not limited to):
- Provide quality oversight for environmental and facilities monitoring programs at a gene therapy manufacturing facility.
- Review, interpret, and ensure proper documentation of data generated to support manufacturing and facility operations.
- Monitor raw materials sampling and testing programs to ensure they align with the product lifecycle and regulatory requirements.
- Lead cross-functional teams in resolving facility-related excursions through effective review and decision-making processes.
- Manage and maintain quality records and documentation across key quality systems: change control, deviations, CAPA, supplier quality, training, and quality review.
- Actively support and promote a culture of quality and compliance in alignment with organizational values and GxP standards.
- Bachelor’s degree in a scientific or engineering discipline.
- 8–10 years of relevant experience in GMP-regulated biopharmaceutical or biotechnology environments, specifically within Quality Assurance.
- Strong knowledge of FDA, EMA, and global GxP regulations; direct experience supporting health authority inspections.
- Proven experience with electronic Quality Management Systems (eQMS) and supplier quality oversight.
- Skilled in driving continuous improvement and facilitating cross-functional collaboration.
- Effective project management and meeting facilitation capabilities.
Come see why DPC has achieved:
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
- Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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