Quality Assurance Analyst
Quality Assurance Analyst
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Job Description
Role: Quality Assurance Analyst
Industry: Pharmaceuticals / Biotechnology / Clinical Research
Location: Fall River Massachusetts USA 100% onsite
Employment Type: Full-Time
Experience Required: 3 Years minimum
Work Authorisation: US Citizen or Green Card Holder
Work Hours: General: 8:30 AM 5:00 PM (May vary depending on business needs)
About The Job:
We are seeking a diligent and detail-oriented Quality Assurance (QA) Analyst I to join a pharmaceutical manufacturing company based in Fall River MA.
This role ensures quality is built into every step of the manufacturing process through real-time monitoring in-process checks and compliance oversight not by performing laboratory testing but by preventing issues before they occur.
You will report to the Quality Assurance Manager and be an essential part of maintaining strict compliance with regulatory standards including Good Manufacturing Practices (GMP) a system designed to ensure products are consistently produced and controlled according to quality standards.
Key Responsibilities:
- Conduct in-process testing (e.g. weight thickness hardness disintegration friability) in accordance with manufacturing batch record instructions.
- Perform room and equipment checks prior to each manufacturing stage following written SOPs.
- Execute Acceptable Quality Limit (AQL) sampling and inspections.
- Inspect in-process and finished product samples for Quality Control (QC) lab handoff and document results precisely.
- Maintain daily verification of balances and calibration standards.
- Ensure proper isolation and documentation of rejected materials during batch production.
- Monitor and record environmental operating conditions during production.
- Review batch documentation temperature logs humidity data calibration and pest control records.
- Verify equipment readiness and proper function throughout the production cycle.
- Support investigations into customer complaints through applicable quality testing and reporting.
- Identify and escalate non-conformances deviations or documentation errors as appropriate.
- Contribute to process improvement initiatives and assist with quality-related projects.
MUST HAVE Qualifications:
- Bachelors degree (BS or BA) in Chemistry or a Physical Science discipline.
- Minimum 3 years experience in quality assurance within a GMP-regulated pharmaceutical manufacturing environment.
- Experience with MDI (Metered Dose Inhalers) or parenterals preferred (solid dosage liquids tablets and capsules also acceptable).
- Vocational training or a degree in pharmaceutical manufacturing industrial management or a related field preferred.
Required Skills:
- Working knowledge of Good Manufacturing Practices (GMP) the industry standard for ensuring product quality and regulatory compliance.
- Strong attention to detail and commitment to documentation accuracy.
- Proficient in Microsoft Office (Excel Word Outlook); SAP or similar systems a plus.
- Excellent communication skills (verbal written and presentation).
- Highly organised self-motivated and capable of handling multiple tasks under deadlines.
- Team-oriented with strong interpersonal relationship-building skills.
- Strong attention to detail and commitment to documentation in Microsoft Office (Excel Word Outlook); SAP or similar systems a plus.
- Excellent communication skills (verbal written and presentation).
- Highly organised self-motivated and capable of handling multiple tasks under deadlines.
- Team-oriented with strong interpersonal relationship-building skills.
Application Process:
To apply please submit your CV and a cover letter detailing your relevant experience and qualifications for the role. Applications will be reviewed on a rolling basis so early submissions are encouraged.
Equal Opportunity Employer:
We value diversity and are committed to creating an inclusive work environment. We encourage applicants from all backgrounds to apply.
Contact: Elvis Eckardt
Required Experience:
IC
Employment Type
Full-Time
