Quality Control Analyst II

BioPharma Consulting JAD Group; Norton (MA); On-site; USD 55,000 - 83,000; Full time

Job summary

BioPharma Consulting JAD Group is seeking a Quality Control Operations Analyst II Contractor in Norton, MA. The position focuses on routine and non-routine analytical testing (HPLC/UPLC) and microbiology, data trending, investigations, and support for method transfers and validation within a GMP environment.

You will assist with lab operations, equipment/inventory management, and maintaining training records, while contributing to SOP updates and regulatory readiness.

Qualifications

• B.S. in chemistry, biology, biochemistry, or related field; 4–8 years of pharmaceutical/biotech GMP QC experience.
• Experience in method transfer/implementation; understanding of method lifecycle management.
• Strong technical writing, data analysis, problem-solving, and organizational skills.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint.

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.

Skills

Analytical testing

GMP QC experience

Data analysis

LabWare LIMS

Technical writing

Problem solving

Education

B.S. in chemistry/biology/biochemistry

Tools

LabWare LIMS

Excel

Word

PowerPoint

Job description

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.

Requirements

• 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
• Strong technical writing, data analysis, problem-solving, and organizational skills
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint

Benefits

• Contract position with possible extension
• Location: Norton, MA, with occasional responsibilities at other locations.
• Weekend coverage is required.
• First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training.