Quality Control Analyst II: Precision Testing & Compliance

BioPharma Consulting JAD Group

Norton (MA)

On-site

USD 55,000 - 83,000

Full time

2 days ago
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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

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.

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