Quality Control Analyst II

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

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.

• 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.

• 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.