Sr. Specialist, Manufacturing Quality
As Senior Specialist in Manufacturing Quality, you will be responsible for the routine Quality oversight and support of facility sterile manufacturing operations. This includes floor support, internal auditing, batch-related documentation review/approval, and qualification/validation support. The Senior Specialist in Manufacturing Quality will support the Quality and Compliance of facility manufacturing activities and contribute to continuous improvement initiatives.
- Provide oversight, review, and approval of all Manufacturing Quality related documents including, but not limited to, change control, specification review/approval, API/excipient/component release, master record review/approval, executed batch record review, product release, deviation/investigation approval, and validation approval.
- Participate in the execution of the internal Quality audit schedule.
- Support Quality Management in the development of site Quality metrics
- Participate in Management Review of metrics as requested.
- Provide support as required for external audits, client audits, and regulatory inspections.
- Provide support and guidance to Operations, Validation, Engineering, and Facilities as warranted.
- Assist Quality management 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
- Six 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 knowledge 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.