Position: Quality Assurance (QA) Specialist
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.
Qualifications:
* 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.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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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Job #17807
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