Alkermes - Quality Control Analyst I

Quality Control Analyst I

GENERAL DESCRIPTION: The position requires the individual to perform routine/non-routine physical, chemical, and in-vitro assays of clinical, commercial, process and cleaning validation samples, and process development samples to support Manufacturing. Performs physical and/or chemical analyses of product to ensure stability. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. KEY DUTIES:• Perform and record analyses as assigned on a daily basis.• Adhere to cGMP’s in all work practices.• Assist in maintaining a clean, safe workplace on a daily basis.• Review peer's work as needed.• Review and revise test methods.• Write and disseminate technical data summaries and reports as needed.• Research and recommend purchase of capital equipment as needed.• Purchase laboratory supplies as needed.• Coordinate sending samples and receiving data from contract laboratories as needed.• Train other colleagues in methods and procedures.• Proactively assist other team members. SKILLS/ABILITIES:• Ability to perform routine analysis, such as wet chemistry and operate basic laboratory equipment.• Understands paperwork review process. • Ability to follow written procedures and exhibit excellent documentation practices.• Basic laboratory knowledge and skills. PERSONAL ATTRIBUTES:• Proactively achieves results for the best of the organization.• Willingness to learn new things.• Ability to function in a small company atmosphere.• Ability to cope with a rapidly changing work environment.• Commitment to teamwork.• Commitment to continuous improvement in all areas.• Ability to focus attention to details and ensure high quality work.• Ability to work safely; seek out and encourage safe practices. EDUCATION AND EXPERIENCE:• Bachelors Degree in Chemistry with 0-2 years of laboratory experience. Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed.