What are the responsibilities and job description for the Quality Assurance Specialist position at Olympia Pharmaceuticals?
General Purpose
The Clinical Pharmacy Liaison is responsible for ensuring quality oversight throughout the production process. Involved in day-to-day documentation and change control processes. Ensuring compliance in all GMP areas including but not limited to document control, change control and auditing program
Job Tasks and Responsibilities
Quality Assurance support for production operations. Responsibilities include, but are not limited to the following:
- Initial review of batch records prior to QA Disposition
- Oversight on Environmental Monitoring & Sampling, Personnel Monitoring Sampling, Aseptic Practices & Insanitary Conditions Monitoring
- Co-owner of visual inspection system. Work within production on the review/approval of visual inspection yields and qualify visual inspectors.
- Ensure qualifications and training of personnel in production.
- Review and provide QA/QC approval to records for Sterilization/Depyrogenation, Cleaning and Sanitization, pre-weigh, and all associated forms within a batch record.
- Act as Program Lead of labeling. Ensure all labels are ordered and are QA approved. Provide oversight on labeling operations, approve production labeling forms, and perform labeling AQL’s
Education and Experience
- AS or BS, microbiology preferred
- 1-3 years QA experience working in a cGMP Drug Manufacturing environment or sterile pharmacy compounding
- Knowledge of relevant regulatory requirements
- EM certification preferred
- Strong computer skills including Microsoft Office and databases
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- No nights
- No weekends
