QC Chemistry Analyst
- Support establishment of a QC sample management program to ensure timely generation and reporting of test results in support of manufacturing operations.
- Ensure time-sensitive distribution of quality control samples in support of QC-related activities
- Perform routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, sample plan generation, sample receipt and distribution, CoA generation, record keeping, etc.
- Manage inventory of reference standards and samples (on-test, retain, reserve, stability) for the QC laboratory.
- Stability sample management.
- Bachelor’s or above in Chemistry or Biotechnology related scientific discipline
- Bachelor’s Degree or above in Chemistry or Biotechnology related scientific discipline.
- Minimum of 2 years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
- 5+ years of experience preferred with no higher education.
- Working knowledge and experience with analytical testing methods.
- Familiar with USP/EP and cGMP/EU GMP regulations.
- Familiar with instrument and equipment validation.
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Credible and confident communicator (written and verbal) at all levels.
- Strong analytical and problem-solving ability.
- Hands-on approach, with a ‘can do’ attitude.
- Ability to prioritize, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Committed to learning and development.
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