Tech Ops and Quality - Quality Control Analyst II
Listed on 2026-08-29
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Data Analyst
Title:
Quality Control Analyst II
Job
Location:
Norton, MA
Duration: 12 months contract ( Possibility of extension)
Shifts & Schedule Weekend / Weeknight team:- Fri–Mon, 4x10 schedule
- Target start time 8:00 AM (30-minute flexibility)
This is an onsite role in Norton, MA, with occasional responsibilities at other client locations. Weekend coverage is required. First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training.
OverviewThe Quality Control Operations (QCO) Analyst II Contractor supports maintaining high standards of quality and compliance from development through commercialization. The role includes performing routine and non-routine testing, participating in data trending, investigations, and lab operations, and supporting method transfers, qualification/validation, verification, and implementation. This position enhances QC efficiency and effectiveness.
Key Responsibilities- Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs
- Support weekend lab operations and maintain training records
- Assist in lab equipment and inventory maintenance, including reagent and sample prep
- Review data timely and qualify as a data reviewer
- Perform operational assignments (raw material processes, environmental monitoring, in-process testing)
- Contribute to updating controlled documents (SOPs, work instructions, test methods)
- Follow internal policies, SOPs, and regulatory standards (GMP, GLP, ICH)
- Participate in continuous improvement initiatives and cross-functional collaboration
- Support regulatory submissions, inspection readiness, and audits
- B.S. in chemistry, biology, biochemistry, or related field
- 4-8 years of pharmaceutical/biotech experience in GMP QC or equivalent
- Experience in method transfer/implementation; understanding of method lifecycle management preferred
- Strong technical writing, data analysis, problem-solving, and organizational skills
- Excellent communication and teamwork
- Proficiency in Lab Ware LIMS, Excel, Word, and PowerPoint preferred
- Bioburden testing
- Endotoxin / biotoxin
- Environmental Monitoring
- Aseptic technique
- GMP experience (required)
- Microbiology some chemistry experience would be ideal
- LIMS experience is preferred
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).