Joulé
6 days ago Be among the first 25 applicants
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
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Staffing and Recruiting Referrals increase your chances of interviewing at Joulé by 2x Sign in to set job alerts for “Quality Control Analyst” roles.
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#J-18808-Ljbffr
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
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Staffing and Recruiting Referrals increase your chances of interviewing at Joulé by 2x Sign in to set job alerts for “Quality Control Analyst” roles.
Middlesex County, NJ $70,000.00-$85,000.00 16 hours ago Middlesex County, NJ $80,000.00-$90,000.00 1 day ago Old Bridge, NJ $63,300.00-$91,700.00 6 days ago Millburn, NJ $81,200.00-$150,800.00 2 weeks ago Quality Document Control Specialist (Cosmetics) - 156698
North Brunswick, NJ $30.00-$35.00 1 week ago Morris Plains, NJ $85,400.00-$158,600.00 1 week ago Raritan, NJ $93,463.00-$122,670.00 6 days ago Piscataway, NJ $40,000.00-$200,000.00 1 month ago Lab Materials and Records Specialist and Patch Preparation Technician
Piscataway, NJ $80,000.00-$85,000.00 10 hours ago Millburn, NJ $81,200.00-$150,800.00 1 week ago Senior Regulatory Compliance/ Quality Assurance
Roselle, NJ $100,000.00-$110,000.00 1 week ago Branchburg, NJ $64,000.00-$122,000.00 1 week ago Cranbury, NJ $294,000.00-$352,666.00 1 day ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr