QC Analyst I

4 weeks ago

Wilmington, Delaware, United States Alkermes, Inc. Full time

GENERAL DESCRIPTION:

The QC Analyst I performs testing of samples submitted to the laboratory in a cGMP compliant manner, as well as according to approved written procedures. The QC Analyst I may be required to write or revise SOPs, analytical procedures, or other analytical documentation at the discretion of quality control supervisory staff.

KEY DUTIES:

  • Perform testing in accordance with written procedures (i.e. USP/EP/JP grade)
  • Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices.
  • Processing of electronic data using procedures that ensure data integrity and security.
  • Ship samples to contract testing facilities.
  • Entry of test results from contract laboratories
  • Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.
  • Transcribe results onto analysis reports.
  • Perform daily standardization and performance verifications on laboratory equipment.
  • Comply with site-wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
  • Identify deviations to written procedures.
  • Disposal of laboratory waste on an as needed basis.
  • Identify and report unsafe conditions within the laboratory.
  • Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation; perform investigative testing.

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
  • analytical techniques in wet chemistry/chromatography
  • Practical experience with various types of laboratory instrumentation
  • Troubleshooting skills with analytical methodology and instrumentation.
  • Technical writing skills
  • Employee must be able to pass a vision exam prior to employment and annually thereafter.

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
  • Responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills

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.

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