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QC Chemist & Documentation Specialist

Jobot
Philadelphia, PA Full Time
POSTED ON 1/28/2025
AVAILABLE BEFORE 2/26/2025
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Job details

QC Chemist & Documentation Specialist - Hiring ASAP!

This Jobot Job is hosted by Jenner Wiggins

Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.

Salary $55,000 - $65,000 per year

A Bit About Us

We are a family-owned contract manufacturer specializing in human and veterinary pharmaceuticals, nutritional, and cosmetic products. We offer comprehensive services including R&D, manufacturing, packaging, and regulatory support, serving clients from startups to Fortune 20 companies with a commitment to high-quality, affordable products.



Why join us?


  • Reputation for high-quality manufacturing.
  • Family owned and a very collaborative team environment.
  • Make an impact in the Pharmaceutical industry.

Job Details

MUST HAVES

  • Analytical hands-on experience in running quality control lab tests on pharmaceutical products using instruments like HPLC, GC, UV-Vis etc.
  • Hands-on experience in running Method Validations on pharmaceutical products using instruments like HPLC, GC, UV-Vis etc.
  • Hands-on experience in preparing method validation protocols, reports, lab investigations, specifications, analytical procedures and other QC documents.

Duties/Responsibilities

  • Gather and review data from chemists in accordance with internal Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
  • Develop specifications for raw materials, finished products, and stability studies.
  • Draft analytical procedures, method validation protocols, stability protocols, and expiration memos.
  • Prepare Certificates of Analysis (COA) and Certificates of Conformance (COC).
  • Represent the Quality department in meetings, providing input and recommendations as needed.
  • Ensure compliance with all safety protocols. Familiarity with GMPs, ICH guidelines, FDA regulations, and other relevant regulatory requirements is preferred.
  • Initiate action or deviation reports for any identified nonconformances.
  • Conduct testing of raw materials, finished products, and additional samples as required.
  • Perform other duties as assigned by management.

Education/Experience

  • Minimum 3 years of quality control or quality assurance experience
  • BS or BA Biology, Chemistry, Biochemistry, or relevant related field, or sufficient technical/professional experience
  • Experience in quality systems including validation, documentation, and compliance
  • HPLC analytical experience is a plus

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Salary : $55,000 - $65,000

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