What are the responsibilities and job description for the QC Equipment Qualification Analyst position at Advantage Technical?
Job Title: QC Equipment Qualification Analyst III (LEQ)
Additional Details
- Location: Norton, MA (fully onsite)
- Schedule: Standard business hours (no weekends)
- Duration: Contract through 12/31/2026 with opportunity to extend
- Pay Rate: ~$53 to $60 an hour or up to about $123,000 a year
Overview
The Quality Control Operations (QCO) Equipment Qualification Analyst III is responsible for ensuring laboratory equipment is qualified, compliant, and fit for intended use throughout its lifecycle. This role supports QC operations by executing and maintaining equipment qualification programs in accordance with USP <1058>, cGMP, and regulatory requirements.
This position plays a key role in maintaining data integrity, supporting audits, and driving continuous improvement across laboratory systems to enhance efficiency and compliance.
This is a fully onsite role based in Norton, MA, with occasional support at a secondary site in Cambridge, MA.
Key Responsibilities
- Execute and support equipment qualification activities (IQ/OQ/PQ) in compliance with USP <1058>
- Classify instruments (Groups A, B, C) and define appropriate qualification strategies
- Review and approve qualification protocols, scripts, and reports
- Manage equipment lifecycle activities including calibration, maintenance, requalification, and change control
- Review vendor documentation (URS, manuals, certificates) for compliance and qualification support
- Investigate and document deviations, discrepancies, and out-of-tolerance events
- Ensure compliance with cGMP, GLP, data integrity, and global regulatory standards (FDA, EMA)
- Collaborate cross-functionally with QC, QA, Facilities, Validation, and external vendors
- Maintain accurate documentation within electronic quality systems (e.g., LIMS, Veeva)
- Support internal audits and regulatory inspections
- Drive continuous improvement initiatives to enhance laboratory efficiency and reliability
Qualifications
- Bachelor’s degree in Chemistry, Biology, Biochemistry, or related field
- 6–10 years of experience in GMP Quality Control or regulated lab environment
- Strong hands-on experience with laboratory equipment qualification
- Deep knowledge of USP <1058> and instrument lifecycle management
- Familiarity with cGMP, GLP, and data integrity principles
- Experience with lab instrumentation such as HPLC, GC, UV/Vis, dissolution, balances, pH meters
- Strong technical writing and documentation skills
- Ability to manage multiple priorities in a fast-paced environment
- Excellent communication and collaboration skills
Preferred:
- Experience with CSV (Computer System Validation) for lab equipment
- Familiarity with LIMS, Veeva, Empower, CMMS/Infor
- Experience supporting regulatory inspections or audits
Ideal Candidate Profile
- Strong GMP background with a focus on equipment qualification/validation
- Experience supporting lab equipment programs (not analytical testing-focused)
- Comfortable working cross-functionally across QC, QA, Facilities, and Maintenance teams
- Able to operate independently while contributing to team objectives
Salary : $123,000