Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.
QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary)
Compliance and quality systems (SOP revisions, input to quality systems records)
Participate in training analysts; troubleshooting of test methods
Education & Experience Requirements:
Normally requires a bachelor's degree and a minimum of 2 years related experience. (Science related degree is preferred)
Additional Specific Experience: None
Specific QC Focus Areas: Product Testing which focuses on techniques such as SDS-PAGE, Western Blot, ELISA, Potency and Bioassays in order to support in-process, release and stability testing.
Other Job Requirements:
Limited to no travel expected.
The following physical abilities are required in order to fulfill the job duties:
-Repetitive bending and reaching to setup and break-down equipment
-Ability to work around chemicals
-Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
-Ability to walk and stand for periods of time
-Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours