Quality Specialist II, Laboratory Data Review
This position is responsible for performing detailed data review of test results generated by the Laboratory group for compliance with cGMP, internal SOPs, and Specifications. The Data Reviewer must pay attention to details and have excellent organizational skills with a large quantity of data.
- Review chemistry and microbiology testing data, lab equipment calibration records, and log-books.
- Manage the data review process to support established timelines associated with the release of raw materials and finished product as well as stability timepoints.
- Ensure required testing documentation is complete and generated with adherence to company policies and procedures.
- Work with analysts to complete any corrections.
- May assist with a review of procedures, protocols, and reports as requested.
- Organize, assemble, and route documentation to support Laboratory approvals of testing steps.
- Provide support to management in other data-related tasks such as guardianship of matrixes and KPI.
- Performs related duties as assigned.
- Pharmaceutical laboratory experience including at least three years in GMP QA/QC/Compliance.
- Experience with Waters HPLC/UPLC, Empower software, and ELN preferred.
- Organized, detail-oriented, and capable of multitasking in a fast-paced environment.
- Experience with Nonconformance/Deviation and CAPA programs is a plus.
Experience in protocol-driven work.
- Ability to work independently, along with the ability to work well within a team, and willing to work overtime or off schedule as needed to meet demands of Center.
- Ability to communicate effectively, both orally and in writing.
- Knowledge of GMP documentation, procedures, and systems.
- Excellent computer skills (Microsoft Word and Excel).
TriPharm Services, Inc. is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. TriPharm complies with all employment eligibility verification requirements of the Immigration and Nationality Act, and all must have the authorization to work in the U.S.