Quality Specialist II, Manufacturing
As a Quality Specialist in Manufacturing Quality, you will be responsible for the routine Quality support of facility sterile manufacturing operations. This includes floor support, internal auditing, and batch-related documentation review. The Quality Specialist will support the Quality and Compliance of facility manufacturing activities and contribute to continuous improvement initiatives.
- Provide oversight, review, and approval of Manufacturing Quality related documents including, but not limited to, excipient/component release, SOP generation/review/approval, executed batch record review, and deviation/investigation review.
- Participate in the execution of the internal Quality audit schedule and routine floor support activities.
- Support Quality Management in reporting of site Quality metrics.
- Provide support as required for external audits, client audits, and regulatory inspections.
- Provide support upon request to Operations, Validation, Engineering and Facilities.
- Assist Quality Management and Sr. Quality staff in strategic review and continuous improvement of Manufacturing Quality processes, training, and related procedures.
- Maintain a culture of collaboration and flexibility in a team environment.
- Ensure Policies and Standard Operating Procedures are in alignment with both organizational and compliance standards.
- Bachelors’ degree or higher is required, preferably in the technical/scientific field, e.g., engineering, chemistry, biology, or mathematics
- Three years of Manufacturing Quality experience in a pharmaceutical manufacturing facility (sterile manufacturing preferred)
- Broad-Based technical knowledge of aseptic processing, cGMPs, and FDA/EMA regulatory requirements
- Working experience of process Microbiology is also preferred
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.