Quality Control Analyst
4 weeks ago
Summary of Position
This position is responsible for performing activities to support analytical testing programs to ensure compliance with cGMP standards including in-process, product release and stability testing. In the role, you will ensure accurate documentation, timely completion of all analytical related testing, and timely review of data, while adhering to standard operating procedures and cGMPs.
Responsibilities and Job Duties:
- Performs routine analytical testing including complex methods such as ELISA, bioassays, and Cell Culture for in process, product release, and stability samples on a daily basis.
- Performs peer review of test data generated by other analysts to identify discrepancies and out of range results and to ensure adherence to standard operating procedures and GMPs.
- Identifies analytical data trends and reports findings and provides recommendations to supervisors for review and consideration.
- Conducts investigation when there are out of specification results from testing and reports to supervisor.
- Initiates and monitors progress of analytical related Quality event records (e.g., Deviations and CAPAs) and conducts investigations to determine root cause and possible resolution.
- Develops, revises, and updates standard operating procedures, as needed.
- Collaborates with Senior QC team members to participate in the development, transfer, and validation of analytical testing methods.
- Conducts training on analytical test methods to other QC Analysts as needed.
- Oversees lab equipment calibration and maintenance processes as required, and raises any concerns about equipment to the supervisor for resolution.
- Participates in troubleshooting analytical test methods and instruments as needed.
- Performs special projects related to problems encountered with analytical testing and instruments, and makes recommendations for solutions that will minimize future issues.
- Mentors and trains lower level analysts as needed.
- Prepares general lab solutions and buffers as needed.
Qualifications
- Bachelors Degree in a scientific discipline and minimum of 4 years experience. Additional years of experience may be considered in lieu of a Bachelors degree.
- Ability to work onsite.
- Recent and relevant experience performing ELISA, Bioassays or Potency testing.
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