Quality Control Analyst II/III

Quality Control Analyst II/III
Location : Piscataway, NJ
Type: Direct Hire
Work Model: Onsite
Hours: MondayFriday, 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: Bachelors in biotechnology, biochemistry, chemistry, or related field with 34 years of QC experience in a pharma/biotech environment.
Level II:
o Bachelors + 6+ years of experience, OR
o Masters + 34 years of experience
Level III:
o Bachelors + 10+ years of experience, OR
o Masters + 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
#LI-
#DI-

Ref: #558-Scientific