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.
EDUCATION
- BS (Required) in Scientific discipline. Microbiology preferred.
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.
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.