QC Analyst II

Chicago, IL 60616

Employment Type: Contract to Perm Job Category: Chemist/ Lab Job Number: MC434567317 Compensation: $33.50 / hour

Job Description

Title: QC Analyst II
Location: Chicago, IL
Hire Type: Contract to Hire
Payrate: $33.50/hour

Overview:
Sterling has helped build careers for thousands of professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S.

As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.

Job Summary: 

The Quality Control Analyst II will conduct analytical tests and verify data for clinical and commercial biosimilar products in cGMP-compliant labs. They'll also work on improving Quality Systems for better efficiency.  A solid grasp of protein chemistry is necessary to use techniques like HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays. They must collaborate across departments to resolve projects and lab investigations promptly.

Job Duties:
  •  Have a good understanding of cGMP, Quality Systems, and ICH/regulatory guidance.
  •  Investigate, document, and review Out of Specification lab investigations, deviations, and plans for corrective and preventative actions.
  •  Collaborate with different teams to progress projects, upkeep equipment, and create documents and reports.
  •  Train fellow analysts on lab procedures and assays. Join internal assessments and audits when needed.
  •  Fulfill any other necessary tasks or assignments.
  •  Adhere to all company policies and standards.

Qualifications:

  • Hold a Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field with a minimum of 5 years of experience in a pharmaceutical/biotech QC laboratory.
  • Alternatively, possess a Master’s degree in the aforementioned fields with 3 years of experience in a pharmaceutical/biotech QC laboratory, or a PhD in the same areas with at least 2 years of experience.
  • Have prior experience in a cGMP laboratory.
  • Possess a strong foundation in protein chemistry and experience in resolving analytical issues.
  • Show proficiency in writing, updating, and adhering to SOPs, protocols/reports, and QC methods.
  • Demonstrate expertise in techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
  • Have previous involvement in supporting regulatory inspections (e.g., PAI).
  • Be familiar with preparing regulatory dossiers and data packages for interactions between regulatory agencies.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identify, national origin, disability, protected veteran status, or genetic information.

Meet Your Recruiter

Justin DiBlasi
Technical Recruiter

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