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.

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

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What You’ll Do

This Contract-to-Hire Quality Assurance Specialist will provide technical QA support within GMP manufacturing operations at a confidential client site. You will work onsite in a multi-product fill/finish facility and partner with Quality, Operations, Engineering, MSAT, Continuous Improvement, and Project Management to resolve quality issues, drive CAPAs, support audits, and improve process robustness.

• Execute routine technical support for GMP manufacturing, sterile filling, and fill-finish operations
• Lead and participate in cross-functional deviation investigations to identify root causes
• Develop, document, and track Corrective and Preventive Actions (CAPAs) and Action Items (AIs)
• Support audit readiness and provide technical documentation and responses during audits
• Perform on-call support and site deviation analysis as needed to resolve manufacturing impacts
• Prepare clear investigation reports, CAPA records, and other quality documentation
• Engage subject matter experts on the manufacturing floor to validate findings and implement practical solutions
• Contribute to targeted innovations and continuous improvement projects (LEAN/Six Sigma practices welcomed)
• Apply root cause analysis tools and quality methodologies within a GMP-regulated environment

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Essential Qualifications

• Bachelor’s degree in life sciences, engineering, or equivalent training/experience
• Up to 3 years entry-level experience in pharmaceutical or GMP manufacturing (entry-level to early-career)
• Strong understanding of GMP principles, quality assurance, and quality control in pharma environments
• Experience or familiarity with deviation investigations and CAPA processes
• Technical writing skills for investigation reports and quality records
• Proficient with Microsoft Word, Excel, and Outlook
• Familiarity with FDA and other applicable regulatory expectations
• Ability to work onsite full-time and participate in an on-call rotation when required
• Strong communication skills and ability to work effectively with cross-functional teams

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Preferred Qualifications

• Experience at a Contract Manufacturing Organization (CMO) or in sterile filling/fill-finish environments
• Exposure to LEAN, Six Sigma, or continuous improvement methodologies
• Hands-on experience with deviation investigations and CAPA implementation in a sterile manufacturing setting

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Work Environment

• Fully onsite role based in a GMP manufacturing facility with frequent floor presence
• Interaction with cross-functional teams in a regulated, production-focused environment
• Standard business software tools (Word, Excel, Outlook) are used routinely
• Must be able to respond to on-call technical support requests and deviation analyses in a timely manner

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Compensation & Benefits

• Pay range: $30.00 - $40.00 per hour (Contract-to-Hire). Actual offer within range depends on experience, qualifications, geographic location, and other factors.
• If eligible, temporary-to-hire benefits may include: medical, dental, vision; 401(k) plan; voluntary life/AD&D; short- and long-term disability; HSA; transportation benefits; employee assistance program; and time-off policies. Benefits vary by eligibility and classification.

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Employment Type & Location

• Employment type: Contract (Contract-to-Hire). This role is expected to convert to direct employment with the confidential client per site policies.
• Workplace type: Fully onsite
• Location: Grand Rapids, MI (onsite at confidential client facility)

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Application Timeline

• Date posted: 2026-10-01
• This posting is anticipated to remain open; applicants are encouraged to apply promptly.

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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.