SUMMARY The Quality Control Inspector ensures Company compliance in its programs to prevent or eliminate deviations in procedures and adherence to cGMP standards. Providing cGMP oversight and guidance to Operations and Logistics departments regarding quality related to documentation, inspection, and manufacturing/packaging processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES - Perform quality control functions including but not limited to component inspections, in-process inspections and finished product inspections according to established procedures.
- Determine proper in-process test standards and assure compliance to same.
- Sampling and inspection of bulk drug and excipients.
- Pull customer/Sharp Clinical Services reserve samples.
- Perform physical testing using basic inspection instrumentation.
- Verify documentation and inspect all shipments in support of distribution.
- Ensure testing is in adherence to current procedures and sampling plans.
- Ensure compliance with cGMPs and Sharp Clinical Services SOPs during Clinical Supply Production and Distribution Instructions during execution of shipping orders.
- Perform daily verification activities (temperature/humidity, weight verifications on balances, etc.).
- Change status of material, GMP Areas, equipment and utensils.
- Maintain accurate, detailed records of work performed.
- Provide timely communication of quality or cGMP issues to supervisor.
- Participate in investigations, deviations, discrepancies, technical problems, procedures, complaints and non-conformance of materials and processes.
- Assist in training employees in cGMPs, SOPs, BRs, Distribution Instructions or quality issues as necessary.
- Work with internal staff to meet scheduled requirements in a timely manner.
- Determine if in-process test results are within established specifications. Responsible for suspending operations and notifying supervisor of any out of specification results.
- Perform pre-production line clearance to the GMP Area prior to the initiation of production.
- Perform verification of drug product and components against approved Manufacturing Instructions prior to the initiation of production.
- Perform verification on cleaned GMP Areas, equipment and utensils.
- Ensure that employees and visitors comply with applicable Sharp Clinical Services, Inc. SOPs.
- Is accountable for maintaining a clean, orderly and safe work environment.
- Adhere to set safety standards.
- Participate actively in regular meetings.
- Achieve expected performance measures.
- Other duties as assigned.