Quality Control Associate Chemist

  •  

Kalamazoo, MI

Industry: Pharmaceuticals & Biotech

  •  

Not Specified years

Posted 156 days ago

  by    Chitrank Rastogi

This job is no longer available.

  • This position is a bench analytical chemist role.
  • The primary responsibilities include testing of raw materials, in-process and finished goods testing.
  • Product approval and product release will be based off of the results of this testing.

Key Responsibilities:

  • Follow site Standard Operating Procedures (SOPs) and Work Instructions (WI)
  • Analyze chemical raw material samples.
  • Analyze chemical bulk solution and finished goods samples for product release.
  • Maintain laboratory records (data integrity).
  • Maintain laboratory instruments.
  • Ability to work overtime and weekends to support manufacturing
  • Responsible for contributing to the continual quality & reliability improvement of APD products and services.
  • Ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy.
  • Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.

Minimum Requirements/Qualifications:

  • Bachelor's Degree in a science related field (i.e. chemistry or biology)
  • Experience in an analytical chemistry laboratory preferred
  • Excellent communication and attention to detail
  • Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude
  • Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
  • Must be willing to work with and around hazardous chemicals.
  • Must possess strong organizational skills.
  • Experience of working with FDA regulated products desired (Medical Device/IVD preferred) (pharmaceutical, dietary supplement or food experience is acceptable).
  • Knowledge of ISO13485 / FDA QSR 21 CFR Part 820 / 803 requirements preferred, 21 CFR Part 110, 111 or 211 is acceptable.
  • Excellent interpersonal skills
  • Excellent communication skills both written & oral
  • Excellent computer skills, particularly spreadsheets/graphical software tools (e.g. Excel)