Quality Control Analyst II/III

  • Piscataway, NJ
  • Posted 19 hours ago | Updated 7 hours ago

Overview

On Site
Full Time

Skills

Management
Project Management
Performance Management
Preventive Maintenance
Biotechnology
Biochemistry
Pharmaceutics
S-PLUS
Good Manufacturing Practice
Manufacturing
Chemistry
SDS
Assays
Documentation
Reporting
Analytical Skill
Testing
Regulatory Compliance
GMP
Collaboration
Quality Management
Quality Control
ELISA
HPLC
SOP
Writing

Job Details

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:
  • 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

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Ref: #558-Scientific
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