Position Summary:
- Performs Weight Check and Quality Attributes Inspection of the product through the filling and packaging process in compliance with company policies/procedures, FDA and cGMP regulations.
- Ensures the accuracy and completeness of batch records.
- Performs other duties as assigned or apparent.
Primary Accountabilities:
- Successfully complete required Quality Assurance Training as outlined per procedure.
- Successfully complete DEA certification.
- Review production batch records for accuracy and completeness.
- Monitor and perform start up, in-process and finished product inspections including weight checks and attribute inspections during production.
- Maintain quality assurance documentation.
- Promote teamwork both within the QA area and other departments.
- Keep line and work station clean and orderly.
- Inspect and release machines and processing rooms for production.
- Support validation and manufacturing studies including special sampling and testing.
- Organize workload during lot and batch changeovers for efficient execution.
- Review and approve production batch records for release into production.
- Investigate out of range percentages.
Shop Floor QA Accountabilities:
- Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.
- Assist with development of solutions for chronic problems within quality assurance
- Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.
- Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
- Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.
- Assist in other activities (as needed) for Quality Assurance management.
