Temp-QC Analyst – 13225

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.