Summary
The primary focus of the Quality Control Associate I role will be to support drug product lot release and in-process testing within a cGMP environment.
Experience
0-3 years of regulated industry experience, or equivalent combination of education and experience.
Knowledge, Skills, and Abilities
Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
Strong analytical and communication skills.
Computer proficiency as well as the ability to master new software programs.
Experience working in a GMP environment is preferred.
Demonstrated success working in a high-performing, business results-driven environment.
DUTIES AND RESPONSIBILITIES :
Perform or support cGMP lot release, in-process, and stability testing using various software packages.
Ensure timely completion of testing and tasks as assigned.
Support assay transfer and method validation of by executing cross-site validation protocols and providing data to support final reports.
Identify opportunities for continuous improvements.
Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner.
Assist in the implementation of new assay methodologies and the associated instrumentation.
Identify and support initiation of Deviations, CAPAs and Laboratory Investigations.
Education
BS in Scientific discipline
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