Temp-QC Analyst

Alkermes•Wilmington, OH

About The Position

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.

Requirements

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.
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.

Nice To Haves

Ability to function in a small company atmosphere.
Ability to cope with a rapidly changing work environment.

Responsibilities

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.