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Senior Quality Specialist
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Senior Quality Specialist (2 Openings – 1st Shift)
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment TypeDescription:
We are partnering with a leading biotech company to fill two Senior Quality Specialist positions on a long-term contract basis. These roles focus on QA operations for advanced cell & gene therapy manufacturing, providing on-the-floor QA oversight, batch disposition, and QC data review.
Key Responsibilities
Provide QA oversight for manufacturing operations, including real-time on-the-floor support in cleanroom environments.
Perform batch disposition activities, including reviewing MBRs, QC data, deviations, and in-process data for product release decisions.
Support deviation investigations, CAPAs, OOS/OOT assessments, and change controls.
Partner with manufacturing, QC, and engineering teams to ensure GMP compliance and inspection readiness.
Review and approve manufacturing documents, COAs, and product release documentation.
Participate in continuous process improvement and risk assessments for GMP processes.
Qualifications
Strong knowledge of GMP regulations, aseptic processing, and quality systems (e.g., TrackWise, Oracle).
Background in pharma/biotech with experience supporting manufacturing or QC operations.
What We’re Looking For in Candidate Submissions
When submitting resumes, please provide: Confirmation of bachelor’s degree (Y/N).
Years of Cell/Gene Therapy QA experience.
Years of commercial QA operations experience.
Years of on-the-floor QA support experience.
Years reviewing MBRs & QC records for lot disposition.
Preferred shift and Req ID.
These roles offer the opportunity to play a critical part in ensuring the quality and compliance of cutting-edge cell and gene therapy manufacturing programs.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
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Title: Senior Quality Specialist (2 Openings – 1st Shift)
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 1+ year contract
- Pay rate: $55-$65/hr
- Job Location: Boston, MA
- Schedule: Mon-Fri, 9am - 5pm
- Job#: bh17995
- Education: Bachelor’s degree in a scientific or allied health field (Master’s preferred).
- Experience:
- Cell/Gene Therapy QA experience (years required)
- Commercial QA Operations experience (years required)
- On-the-floor QA support experience (years required)
- MBR & QC records review for lot disposition (years required)
We are partnering with a leading biotech company to fill two Senior Quality Specialist positions on a long-term contract basis. These roles focus on QA operations for advanced cell & gene therapy manufacturing, providing on-the-floor QA oversight, batch disposition, and QC data review.
When submitting resumes, please provide:
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
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Meet Your Recruiter
Caroline Driscoll
Account Manager & Sr. Technical Recruiter
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