Sr. Specialist, Laboratory Quality
The position is responsible for performing detailed review of test results and associated data generated by the TriPharm Laboratory groups for compliance with cGMP, internal SOPs and Specifications. This position will also support other Quality aspects of the laboratory including equipment qualification, deviation/investigation review, CAPA planning, equipment qualification and method validation. The Sr. Quality Specialist must have good organizational skills and be able to manage multiple tasks with competing priority.
- Review chemistry and microbiology testing data, lab equipment calibration records and log-books, and other review functions as needed.
- 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.
- Perform data and documentation review that is associated with laboratory equipment qualification, deviations/investigations, CAPA, and method validation.
- Work with analysts to complete any corrections and Quality management to facilitate continuous improvement for both laboratory and Quality processes.
- Assist with technical writing and review of procedures, complex protocols, and reports.
- 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 six years in GMP QA/QC/Compliance.
- Experience with Waters HPLC/UPLC, Empower software, and ELN preferred.
- Working knowledge of laboratory Microbiology testing desired.
- Organized and detail-oriented.
- Ability to multitask in a fast-paced environment.
- Experience with Nonconformance/Deviation and CAPA programs.
- Experience in laboratory equipment qualification and method validation desired.
- 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 as related.
- 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.