Quality Control Analyst II
Joulé
Piscataway, NJ
JOB DETAILS
SALARY
$75,000–$82,000 Per Year
SKILLS
Analysis Skills, Assays, Biochemistry, Biological Assay, Biotech and Pharmaceutical, Chemistry, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Drug Manufacturing, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), High Performance Liquid Chromatography (HPLC), ICH Regulations, Identify Issues, Investigative Reports, Laboratory, Quality Control, Regulations, Small Molecules, Standard Operating Procedures (SOP), Team Player, Technical Writing, Willing to Travel, Writing Skills
LOCATION
Piscataway, NJ
POSTED
2 days ago
Location: Piscataway, NJ (Onsite: some travel to South Plainfield)
Hours / Schedule: Monday-Friday, 8:30AM-5:00PM (with occasional early / late hours once per month during production runs)
Type: Direct Hire
Compensation: $75,000 - $82,000 (based on experience)
Overview
Join a growing biopharmaceutical company that is expanding its Quality Control operations! This is a unique opportunity to advance your career in a collaborative, cutting-edge environment where you’ll work with both late-stage clinical and commercial small molecule and biosimilar products. Candidates with GMP, regulatory knowledge, protein chemistry and analytical troubleshooting sought this role.
- Level II: 6+ years (Bachelor’s) or 3-4 years (Master’s)
- Level III: 10+ years (Bachelor’s) or 8+ years (Master’s)
- Execute analytical testing for in-process, raw material, release, and stability samples
- Perform and troubleshoot methods including HPLC (Empower)
- Troubleshoot SDS-PAGE, cell-based bioassays, ELISA, capillary electrophoresis, and compendial assays (although some experience in this area is desired, training be provided).
- Document results in compliance with GMP, ICH, and FDA standards
- Author and revise SOPs, QC methods, technical reports, and investigation summaries
- Support batch release, batch record reviews, and regulatory dossier preparation
- Lead and/or support laboratory investigations, deviations, OOS results, and CAPAs
- Participate in Quality Events and regulatory inspections (e.g., PAI)
- Collaborate with cross-functional teams to ensure laboratory readiness and continuous improvement
- Bachelors Degree in biotechnology, Biochemistry, Chemistry or related field.
- Strong Quality Control experience in a pharmaceutical manufacturing environment.
- Previous cGMP laboratory experience - required
- 3 - 10 + years of experience with a major focus on QC work.
- Proficiency with HPLC and Empower required (must be on resume)
- SDS-PAGE, cell-based bioassays, ELISA, capillary electrophoresis, and compendial assays a plus (training will be provided – must be willing to learn and execute these tests- an opportunity to gain experience and expand your skill set).
- Expertise in small molecules and protein chemistry
- Ability to troubleshoot analytical data and interpret/report results accurately
- Experience supporting regulatory inspections and preparing data packages/dossiers strongly desired
- Strong technical writing & documentation skills (SOPs, QC methods, reports)
This position is a direct hire position with benefits.
Keywords: HPLC, UPLC, Empower, SDS-PAGE, CE-SDS, capillary electrophoresis, ELISA, cell-based bioassay, potency, protein chemistry, biologics QC, biosimilars, cGMP, GMP, OOS, OOT, deviations, CAPA, stability testing, raw material testing, in-process testing, batch release, data integrity, SOP writing, regulatory dossier, CMC, PAI, FDA inspection, SVP, subvisible particles, USP <1788>, LIMS, QMS
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About the Company
J
Joulé
With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:
- Scientific staffing for hard-to-find skills
Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.
- Clinical lifecycle recruiting
From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.
- Equipment calibration, maintenance and validation
Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.
- National healthcare recruitment
Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.
COMPANY SIZE
500 to 999 employeesINDUSTRY
Biotechnology/Pharmaceuticals
WEBSITE
https://www.jouleinc.com/