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QA Associate, Quality Operations
20 Commerce Way Norton, MA 02766 US
Job Description
The QA Associate will help ensure that life-changing biopharmaceutical products are manufactured to the highest standards. The QA Associate will provide day-to-day QA support across manufacturing, validation, materials, QC, engineering and facility operations at our Norton site, partnering with cross-functional teams to maintain GMP compliance and inspection readiness.
Key Responsibilities
•Provide raw material support, including review/approval of incoming material documentation and release for GMP use.
•Deliver on-the-floor QA support to manufacturing, including area clearance and changeover operations, ensuring readiness for production activities.
•Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and quality documents.
•Generate and maintain Quality-related SOPs and controlled forms.
•Review and approve validation documents and protocol executions to confirm compliance with approved procedures and regulatory requirements.
•Review and approve QC laboratory qualification documents, including equipment qualification.
•Perform executed batch record review and approval to ensure accuracy and compliance.
•Review and approve deviations, CAPAs, Change Controls and related investigations in the quality management system.
•Support partner audits and regulatory inspections, including document retrieval and subject matter input.
•Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance.
•Collaborate with internal cross-functional teams at the Norton facility to drive continuous improvement and quality excellence.
Qualification/Skills
•Bachelor’s degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, etc.) or equivalent experience.
•2–4 years of GMP experience in Quality, Manufacturing, or QC.
•Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices.
•Strong attention to detail, organizational skills, and the ability to communicate effectively across teams.
•Experience with quality systems (e.g., Veeva, SAP) is a plus.
Pay ranges between $42-48/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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