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Quality Control Analyst II

2 months ago


Exton, Pennsylvania, United States Hired by Matrix Full time
Are You Ready to Elevate Your Career?

Hired by Matrix is seeking a dedicated QC Analyst 2 to join a leading global pharmaceutical organization. We are committed to connecting talented individuals with companies that prioritize their contributions and foster positive work environments.

Key Responsibilities:
  • Ensure operational success by delivering precise, GxP-compliant evaluations of clinical biopharmaceutical products while actively participating in assay qualification and validation studies.
  • Recognize the significance of biopharmaceutical manufacturing, where each run can exceed $1 million, and stability studies can cost several hundred thousand dollars, emphasizing the importance of accurate release and stability testing.
  • Assist in maintaining laboratory systems, provide training to fellow analysts, uphold SOPs and documentation, and promote a well-organized and efficient laboratory setting.
Qualifications:
  • Bachelor's degree in biological or chemical sciences or a related field.
  • 2-4 years of relevant experience in a cGMP Quality Control, analytical development, or validation department within an FDA-regulated environment.
  • Understanding of QC testing principles, concepts, and practices for protein biopharmaceuticals.
  • Hands-on experience with techniques such as HPLC, capillary electrophoresis, ELISA, or SDS-PAGE for recombinant protein analysis.
  • Familiarity with GxP requirements and ICH/FDA/EMA guidelines.
  • Proficient in identifying and assisting in the investigation of assay and equipment issues.
  • Fluent in English with strong written and interpersonal communication skills.
  • A collaborative team player capable of thriving in a hands-on, entrepreneurial atmosphere.
  • Physical capabilities to handle laboratory equipment, chemicals, and biological materials.
Position Type: Contract

About Hired by Matrix:
Since 1986, we have been dedicated to enhancing the careers of our candidates by providing exceptional job opportunities that lead to significant career growth. We offer competitive salaries, benefits after 60 days, and a 401k option with a company match after one year. Hired by Matrix is proud to be an Equal Opportunity Employer and is certified as both a Woman-Owned Business Enterprise and a Woman-Owned Small Business.