Quality Control Analyst II; Onsite, Weekend

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.

Overview
The 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

Qualifications
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

Ideal skills and experience:
– Bioburden testing
– Endotoxin / biotoxin
– Environmental Monitoring
– Aseptic technique
– GMP experience (required)

• Microbiology some chemistry experience would be ideal

• LIMS experience is preferred

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