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 test methods derived from the various compendia and non-compendial sources. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC laboratory areas. 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
Individuals with sufficient experience and performance to obtain the Analyst III level will generally perform lower % of sample testing and higher % of the other listed responsibilities.
Education & Experience Requirements:
Normally requires a bachelor’s degree and a minimum of 2 years of related experience. (Science related degree is preferred) Additional Specific Experience: Previous experience in a GMP QC role is preferred.
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