Quality Control Analyst II: Elevate Lab Rigor & GMP

BioPharma Consulting JAD Group; Norton (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

BioPharma Consulting JAD Group in Norton, MA is seeking a Quality Control Operations (QCO) Analyst II Contractor to perform routine and non-routine analytical testing (HPLC/UPLC and microbiology) for raw materials, in-process samples, product release, and stability studies, following SOPs.

You will support weekend operations, training records, equipment maintenance, data review, and method transfers, contributing to GMP/GLP/ICH compliance, document control, and continuous improvement in a

Qualifications

• B.S. in chemistry, biology, biochemistry, or related field; 4-8 years of pharmaceutical/biotech GMP QC experience.
• Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays following SOPs.
• Support weekend lab operations and maintain training records.
• Review data timely and qualify as a data reviewer; perform raw material processes, environmental monitoring, in-process testing.
• Contribute to updating SOPs, work instructions, test methods.
• Follow GMP, GLP, ICH; participate in continuous improvement and cross-functional collaboration.
• Support regulatory submissions, inspection readiness, and audits.
• Experience in method transfer/implementation; understanding of method lifecycle management.
• 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

Data analysis

Technical writing

Problem solving

Organizational skills

Excel

LabWare LIMS

GMP/GLP/ICH knowledge

Education

B.S. in chemistry, biology, biochemistry, or related field

Tools

LabWare LIMS

Excel

Word

PowerPoint

Job description

BioPharma Consulting JAD Group in Norton, MA is seeking a Quality Control Operations (QCO) Analyst II Contractor to perform routine and non-routine analytical testing (HPLC/UPLC and microbiology) for raw materials, in-process samples, product release, and stability studies, following SOPs.

You will support weekend operations, training records, equipment maintenance, data review, and method transfers, contributing to GMP/GLP/ICH compliance, document control, and continuous improvement in a