Nature and ScopeTo provide a comprehensive Quality compliance review of cGMP analytical data and results for raw materials, in process and finished product release, stability program results and summaries, and raw data related to the Validation of pharmaceutical processes. To facilitate corrections and clarifications to the reviewed data and provide a final approval of the records.
Essential Duties and ResponsibilitiesNothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
- Provides quality assurance review of laboratory raw data and reports including analytical worksheets, test
- summaries and stability summaries.
- Participates in identifying quality process improvements to increase efficiencies and performance of
- systems, operations and personnel relating to the QA Data Review process.
- Writes and revises SOP's and other GMP documentation as needed.
- Ensures all work is performed and documented in accordance with existing Company policies and
- procedures, as well as cGMP, compendia, and all applicable FDA Guidance document requirements and
- other company requirements.
- Participates in other Quality System activities with other team members as needed.
- Perform any other tasks/duties as assigned by management.
Education Requirements and QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Bachelor's degree in the Physical Sciences, Mathematics or related field or associate degree with
- experience in data review required.
- Minimum 2 years' experience in a chemical testing, laboratory setting with a working knowledge of wet
- chemistry and instrumental analysis techniques or at least 1 year of data review experience.
- Demonstrates extreme attention to detail to achieve quality results.
- Ability to perform multiple activities at the same time and produce outstanding results to meet required
- deadlines.
- Exercises a willingness to learn and take on added responsibilities as needed.
- Excellent organizational, interpersonal and communication skills (oral and written) to work in a team
- environment.
- Ability to work overtime as needed.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email ...@americanregent.com.