Quality Control Analyst II

System One; Piscataway Township (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a QC Analyst II to enhance their QC laboratory's efficiency. This role involves conducting analytical testing, collaborating across departments, and ensuring compliance with cGMP standards, perfect for candidates with substantial expertise in protein chemistry and analytical techniques.

Benefits

Health and Welfare Benefits

401(k) Plan

Life Insurance

Voluntary Benefits

Dental and Vision Coverage

Qualifications

• 8 years QC experience in pharma/biotech with Bachelor's or 6 years with Master's.
• Prior experience in a cGMP laboratory is essential.
• Strong knowledge in protein and small molecule chemistry.

Responsibilities

• Perform analytical testing and data verification.
• Document and investigate Out of Specification results.
• Collaborate across departments on project issues and process improvements.

Skills

Analytical Testing

Data Verification

Troubleshooting

Collaboration

Documentation

Education

Bachelor’s degree in Biotechnology, Biochemistry, Chemistry or related field

Master’s Degree in Biotechnology, Biochemistry, Chemistry or related field

Tools

HPLC

SDS-PAGE

ELISA

Capillary Electrophoresis

Job description

Job Title: QC Analyst II
Location: Piscataway, NJ
Hours/Schedule: M-F, 8:30 am – 5:00 pm (May require extended hours or weekends during manufacturing runs)
Type: Direct Hire / Permanent

Overview
We are seeking a QC Analyst II with a strong background in small molecule and protein chemistry to support our client’s QC laboratory in a cGMP-compliant environment. The role involves analytical testing and data verification to support both late-stage clinical and commercial products, including biosimilars. The ideal candidate will be skilled in troubleshooting analytical results and working with cross-functional teams on projects, process improvements, and laboratory investigations.

Responsibilities

• Perform analytical testing and data verification to support in-process, release, raw materials, and stability programs.
• Conduct testing using HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, and ELISA.
• Collaborate across departments to resolve project issues, conduct lab investigations, and implement process improvements.
• Document and investigate Out of Specification results, deviations, and implement corrective actions.
• Support regulatory inspections and prepare dossiers for agency interactions.
• Maintain laboratory equipment and comply with all company policies, standards, and regulatory guidance.

Requirements

• Bachelor’s degree in Biotechnology, Biochemistry, Chemistryor related field with a minimum of 8 years of QC experience in pharma / biotech.

• OR Master’s Degree in the above fields with 6 years of QC experience in pharma / biotech

• Prior experience in a cGMP laboratory is essential

• Strong knowledge in protein and small molecule chemistry and proficiency with techniques such as HPLC, SDS-PAGE, ELISA, and capillary electrophoresis
• Experience with SOPs, QC methods, and regulatory dossiers
• Demonstrated ability to support regulatory inspections (e.g. PAI)

  Working Environment

• Primarily lab-based with some office work for documentation
• Must be able to lift 25 lbs
• Travel up to 5%-10% as needed (between Piscataway and South Plainfield locations)

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

#M3

Ref: #558-Scientific