What are the responsibilities and job description for the QC Supervisor - Raw Materials position at Exela Pharma Sciences?
Position Summary
The QC Raw Materials Supervisor will report directly to quality upper management, (QC Director), and will provide both managerial and scientific (hands on) leadership as part of the QC - Chemistry group. The incumbent will participate in strategic and technical planning for the QC - Chemistry group, and will be responsible for establishing testing time lines, executing the plan and monitoring the results. The incumbent will be responsible for leading and developing QC - Chemistry scientists that support the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration. The individual will be responsible for implementing policies and procedures that improve safety and productivity of his/her group.
Job Responsibilities
- Write and Implement Standard Operating Procedures according to cGMP and cGLP.
- Assist in validation of new test methods for raw material, in-process, and finished product per USP and FDA guidance
- Provides work assignments with communication of the expected timelines to employees
- Performs any analytical testing to support business needs such as raw material, in-process, method transfer, release, and/or stability testing.
- Reviews and approves documents to release of components, raw materials and drug products.
- Provides troubleshooting support as needed
- Performance and documentation of laboratory investigations
- Internal auditing and handling of external audits by customers and FDA during departmental review
- Purchase equipment and materials
- Hire and train staff
- May handle hazardous waste as required to dispose of laboratory solutions. Basic RCRA training is required for all employees of the laboratory and continuing RCRA training will be performed on an annual basis. New hires may only handle hazardous waste prior to attending RCRA training if they are under the supervision of a RCRA trained employee. RCRA training will be attended within six (6) months of hire.
- For personnel performing additional hazardous waste activities beyond routine discarding of hazardous waste into satellite containers, additional training is required per SOP-QC-000034 and documented on FORM-000904.
Education Requirements
- Master’s Degree/Bachelor’s degree in Chemistry or related scientific discipline with approximately 5 years industry in QC - Chemistry and 2 years leadership experience
