- 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.
- 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.
- 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
- 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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QC Analyst I - Wilmington, United States - Alkermes, Inc.
Description
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:
SKILLS/ABILITIES:
PERSONAL ATTRIBUTES:
EDUCATION AND EXPERIENCE:
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