What are the responsibilities and job description for the Quality Control Analyst II/III position at Joulé?
Job Title: Quality Control Analyst II/III
Location: Piscataway, NJ
Type: Direct Hire
Work Model: Onsite
Hours: Monday–Friday, 8:30 AM – 5:00 PM (may start earlier or stay later once a month during manufacturing runs)
Salary: Competitive and depending upon experience
Travel: 5%–10% (80% Piscataway, 20% South Plainfield)
Interview Process: Onsite with Director, team peers, and HR
Overview: Our client is expanding their QC operations, great opportunity to work with an outstanding company.
Education & Experience Requirements:
• Level I: Bachelor’s in biotechnology, biochemistry, chemistry, or related field with 3–4 years of QC experience in a pharma/biotech environment.
• Level II:
o Bachelor’s 6 years of experience, OR
o Master’s 3–4 years of experience
• Level III:
o Bachelor’s 10 years of experience, OR
o Master’s 8 years of experience
Must-Haves:
Location: Piscataway, NJ
Type: Direct Hire
Work Model: Onsite
Hours: Monday–Friday, 8:30 AM – 5:00 PM (may start earlier or stay later once a month during manufacturing runs)
Salary: Competitive and depending upon experience
Travel: 5%–10% (80% Piscataway, 20% South Plainfield)
Interview Process: Onsite with Director, team peers, and HR
Overview: Our client is expanding their QC operations, great opportunity to work with an outstanding company.
Education & Experience Requirements:
• Level I: Bachelor’s in biotechnology, biochemistry, chemistry, or related field with 3–4 years of QC experience in a pharma/biotech environment.
• Level II:
o Bachelor’s 6 years of experience, OR
o Master’s 3–4 years of experience
• Level III:
o Bachelor’s 10 years of experience, OR
o Master’s 8 years of experience
Must-Haves:
- cGMP laboratory experience
- Strong QC experience in a manufacturing environment
- Solid background in small molecule and protein chemistry
- Skilled in HPLC (Empower), SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and compendial assays
- Experience troubleshooting analytical results
- Familiarity with regulatory dossiers and supporting inspections (e.g., PAI)
- Strong documentation skills: writing/revising SOPs and QC methods
- Ability to process, interpret, and report analytical data
Key Responsibilities:- Perform analytical testing for in-process, release, raw material, and stability samples
- Support both late-stage clinical and commercial small molecule and biosimilar products
- Investigate non-conformances and contribute to Quality Events
- Author technical documents, reports, and investigation summaries
- Support regulatory inspections and ensure compliance with ICH and GMP standards
- Collaborate with cross-functional teams to maintain equipment and improve lab processes
Work Environment:- Office and laboratory setting
- Must be open to extended or weekend hours, as needed
- Fast-paced and deadline-driven environment
Organizational Info:- Business Unit: Quality Management
- Department: Quality Control
- Reports to: QC Director
Keywords: SVPs, USP 1788, Bioassay, Mammalian, ELISA, HPLC, Empower, Regulatory Dossiers, Regulatory Inspections, PAI, SOP Writing
#M
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Ref: #558-Scientific
- Business Unit: Quality Management
- Office and laboratory setting
- Perform analytical testing for in-process, release, raw material, and stability samples
