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, engineering & sciences services and talent solutions.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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What You’ll Do

The Confidential Client is seeking an entry-level Quality Assurance Specialist to provide on-the-floor QA oversight for GMP manufacturing operations at the Plainville, CT site. Core responsibilities include:

• Perform GMP quality oversight during manufacturing operations and maintain a presence on the production floor.
• Review executed batch records, batch documentation, and GMP logs for accuracy, completeness, and compliance.
• Support investigations, deviations, CAPAs, and change controls under direction of senior QA staff.
• Escalate quality events, compliance risks, and atypical observations promptly.
• Partner with Manufacturing, QC, and support functions to ensure adherence to approved procedures and GMP requirements.
• Support internal and client audits and inspection readiness activities.
• Maintain working knowledge of applicable FDA/EMA/ICH regulations, site SOPs, and quality systems.

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Shift & Schedule

• Night shift — Flex 12 rotating schedule
• Week 1: Monday, Tuesday, Friday, Saturday
• Week 2: Sunday, Wednesday, Thursday
• Shift hours: 6:45 PM to 7:15 AM (includes 30-minute unpaid lunch)
• This is a fully onsite role in Plainville, CT.

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Compensation & Benefits

• Pay range: $32.20 - $34.50 per hour (Contract)
• Benefits for eligible temporary employees may include: medical, dental & vision; 401(k) options; voluntary life & AD&D; short- and long-term disability; HSA; transportation benefits; Employee Assistance Program; PTO (as applicable). Benefits depend on classification and eligibility.

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Qualifications

Required / accepted minimums:

• Entry-level — Bachelor’s degree preferred (technology, engineering, microbiology, or related field) OR equivalent combination of education and relevant experience.
• Working knowledge of FDA, EMA, and applicable GMP regulations.
• Basic understanding of deviations, CAPA, investigations, and change control processes.
• Ability to review GMP documentation with attention to detail.
• Proficiency with electronic quality systems and Microsoft Office applications.
• Strong written and verbal communication, organization, and problem-solving skills.
• Ability to gown and work in classified manufacturing areas and to use required PPE.
• Ability to lift up to 25 lbs occasionally and perform frequent standing/walking and computer work.
• Availability to support operations during non-standard hours as business needs require.

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Preferred / Helpful Experience

• Familiarity with CAPA systems, change control, and risk management.
• Prior exposure to GMP manufacturing operations, audits, or inspection readiness activities.

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Workplace & Employment Type

• Employment type: Contract (on-site)
• Location: Plainville, CT (must be able to commute to the site)
• Experience level: Entry Level

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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.