Job Description
A biotech organization in Massachusetts is seeking a Senior Quality Control Analyst I for a data review role. This position supports gene therapy quality control activities by reviewing analytical data, ensuring compliance, and helping maintain the integrity and timeliness of product release decisions.
About the Opportunity:
- Shift: Day
- Schedule: Monday to Friday
- Hours: Standard business
- Setting: In-person
Responsibilities:
- Review and approve cGMP analytical data packages generated by internal and external laboratories
- Verify analytical data for accuracy, completeness, compliance, and alignment with approved methods and regulatory requirements
- Examine raw data, electronic records, calculations, chromatograms, and worksheets
- Assess data integrity, audit trail compliance, and adherence to ALCOA+ principles
- Collaborate with internal teams and external laboratories to resolve data discrepancies and support product release activities
Qualifications:
- 5+ years of industry experience in a GMP or GLP environment
- Bachelor's or master's degree in Cell Biology, Molecular Biology, Biochemistry, or a related field
- Strong experience reviewing analytical data from molecular biology, bioassay, biochemical, or microbiological testing
- Thorough understanding of cGMP regulations, FDA data integrity guidance, ALCOA+ principles, and quality systems
- Excellent attention to detail, problem-solving, communication, and organizational skills
Desired Skills:
- Experience with qPCR, ddPCR, ELISA, cell-based assays, HPLC, electrophoresis, or similar analytical platforms
- Familiarity with LIMS, ELN, Empower, SoftMax Pro, JMP, BioRad QuantaSoft, or comparable tools
- Experience supporting deviations, investigations, CAPAs, OOS, OOTs, change controls, audits, inspections, SOPs, or procedure updates
Numbers & Facts
| Location | Woburn, Massachusetts |
| Industry | Staffing/Employment Agencies |
| Salary | $40–$50 Per Hour |
| Company Size | 100 to 499 employees |
| Year Founded | 1985 |
| Website | http://www.tandymgroup.com |
About Company
At Tandym Group (formerly The Execu|Search Group), we’re committed to connecting talented people like you with leading companies. With our personalized approach, you’ll never feel like just a resume when you work with us. We know that every job—and every job seeker—is different, which is why we keep the focus on you and your goals. This philosophy has allowed us to help thousands of people find career success over the last three decades, and we’re here to help you do the same.
With our extensive network of companies and full suite of direct hire recruitment and contract staffing services, you’ll have access to a variety of roles. We match talent with highly curated opportunities across healthcare, professional services, tech, and life sciences—but it goes far beyond that.
When you partner with us, we’re all in. Your goals become our goals, and we are committed to helping you reach your highest potential. From matching you with your dream role to providing resume guidance and interview prep, we’re here for the entire journey. In the constantly changing world of work, you can count on us to be by your side.
With our extensive network of companies and full suite of direct hire recruitment and contract staffing services, you’ll have access to a variety of roles. We match talent with highly curated opportunities across healthcare, professional services, tech, and life sciences—but it goes far beyond that.
When you partner with us, we’re all in. Your goals become our goals, and we are committed to helping you reach your highest potential. From matching you with your dream role to providing resume guidance and interview prep, we’re here for the entire journey. In the constantly changing world of work, you can count on us to be by your side.
Skills
- Analysis Skillsunmatched
- Assaysunmatched
- Biochemistryunmatched
- Biological Assayunmatched
- Biotech and Pharmaceuticalunmatched
- Cell Biologyunmatched
- Change Controlunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Data Analysisunmatched
- Data Qualityunmatched
- Detail Orientedunmatched
- Droplet Digital PCR (ddPCR)unmatched
- FDA Requirementsunmatched
- GLP (Good Laboratory Practices)unmatched
- GMP (Good Manufacturing Practices)unmatched
- Gene Therapyunmatched
- High Performance Liquid Chromatography (HPLC)unmatched
- Laboratoryunmatched
- Laboratory Information Management System (LIMS)unmatched
- Maintain Complianceunmatched
- Microbiologyunmatched
- Molecular Analysisunmatched
- Molecular Biologyunmatched
- Organizational Skillsunmatched
- Problem Solving Skillsunmatched
- Product Supportunmatched
- Quality Controlunmatched
- Real-time PCR (qPCR)unmatched
- Regulatory Requirementsunmatched
- Standard Operating Procedures (SOP)unmatched
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