What are the responsibilities and job description for the Quality Control Specialist position at Belmar Pharma Solutions?
Role and Responsibilities
This position is responsible for working cross functionally to support Quality Assurance & Quality Control tasks, with focus on QC job functions. The Quality Control Specialist will support Belmar Pharma Solutions in carrying out the mission of the company. This position reports to the Quality Manager.
Responsibilities include:
- Environmental Monitoring (EM):
- Review EM sampling and trending data
- Quarterly trending will be presented to operations staff and upper management as requested
- Own deviations/investigations related to EM program
- Become point of contact for EM related inquiries for the facility
- Monthly/Quarterly Bioburden and Dose Audit tasks:
- Own monthly bioburden testing program and quarterly dose auditing program
- Ensure testing is performed and results are trended
- Own any deviation/investigation related to bioburden and dose auditing testing
- Review weekly/as needed temperature, pressure, and relative humidity data and escalate OOS events to deviation, owning deviation/investigation
- Assist with owning other deviations/investigations as required
- Communicate with 3rd party labs regarding sample submissions and OOS results
- Conduct Standard Operating Procedure (SOP), Work Instruction (WI), and other controlled document revisions for Quality processes
- Write and execute Change Controls for Quality processes
- Attend all required meetings and provide clear, professional verbal and email communications
- Special project as assigned by management
- EMPQ management for new cleanroom spaces
- Support initial instrument qualification activities for viable samplers and particle counters
- Other duties as assigned to support growing Quality team, including performing QC Technician tasks as requested
