- 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.