Quality Assurance Specialist
The Quality Assurance Specialist is responsible for ensuring compliance with GMP regulations and quality standards at the manufacturing site through oversight of production activities, batch record review, and support of quality system processes such as CAPA and change control. This role collaborates with manufacturing and quality teams to maintain regulatory compliance, support audits, and promote continuous improvement of the site's quality management system.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
What You’ll Do
- Provide on-the-floor Quality Assurance (QA) oversight of GMP manufacturing operations at the Plainville, MA site.
- Review executed batch records and GMP documentation for accuracy, completeness, and compliance.
- Support investigations, deviations, CAPAs, and change controls under guidance from senior QA staff.
- Escalate quality events, compliance risks, and atypical observations in a timely manner.
- Partner with Manufacturing, QC, and support functions to ensure adherence to approved procedures.
- Support internal audits, client audits, and inspection readiness activities.
- Maintain knowledge of applicable GMP regulations (FDA, EMA, ICH), site procedures, and quality systems.
- Contribute to continuous improvement of the site quality management system and quality culture.
Qualifications
- Bachelor’s degree preferred (Life Sciences, Microbiology, Chemical/Biochemical Engineering, or related). Equivalent combinations of education and experience accepted.
- Minimum 1+ years of GMP-related industry experience.
- Basic knowledge of deviations, CAPAs, investigations, and change control processes.
- Working knowledge of FDA and EMA GMP regulations.
- Ability to routinely work in controlled manufacturing and cleanroom environments and comply with required PPE and gowning procedures.
- Ability to lift up to 25 pounds occasionally and perform frequent standing/walking.
Skills & Tools
- GMP compliance and manufacturing oversight
- CAPA and change control support
- Batch record review and documentation accuracy
- Investigation and deviation support
- Electronic quality systems and Microsoft Office proficiency
- Strong written and verbal communication
- Attention to detail, time management, and problem-solving
Schedule & Work Details
- Job type: Contract — fully onsite in Plainville, MA.
- Shift: Day shift — Flex 12 rotating schedule
- Week 1: Mon, Tue, Fri, Sat
- Week 2: Sun, Wed, Thu
- Typical hours: 6:45 AM to 7:15 PM (30 min lunch)
- This role requires routine presence on the manufacturing floor and ability to support non‑standard hours as business needs require.
Compensation & Benefits
- Pay range: $28.00 - $30.00 per hour.
- Compensation offered will depend on qualifications, experience, and other job-related factors.
- If eligible, temporary-role benefits may include: medical, dental & vision, 401(k) options, voluntary life/AD&D, short/long-term disability, HSA, transportation benefits, EAP, and paid time off — eligibility rules apply.
About the Employer
- Confidential Client (Scientific & QA) — client is a leader in engineering and scientific services supporting regulated manufacturing. You will be employed by the confidential client if selected through Careertakes.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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