The Quality Assurance Associate is responsible to communicate and maintain the Quality
System for an assigned project/distribution center. Communicate the quality policy and
objectives and ensure prescribed objectives are met. In this position you will identify
training needs and work with the QA staff to develop and implement an effective training plan consistent with company training.
Essential Duties and Responsibilities:
- Conducting monthly internal GMP audits as directed by QA Supervisor/Manager
- Conducting daily walkthroughs of assigned projects
- Releasing “Quarantined” product into good upon the receipt of documentation from the client
- Monitoring inventory adjustments by reviewing data gathered by operations personnel
- Notifying Operations Manager and QA Supervisor/Manager of any unusual trends
- Conducting random checks of inbound receipt put always for accuracy
- Verifying that the system is identifying “quarantined” product accurately
- Verifying that the system is identifying “released” product accurately.
- Work closely with Operations to identify and correct any system or human generated discrepancies inclusive of corrective and preventative action.
- Assist in trending data to look for ways to improve quality processes.
- Verify that the system is identifying “quarantined” product accurately
- Guide warehouse in determining root cause of discrepancies and the development of corrective actions
- Make suggestions on quality improvements and facilitate change control process when changes are made
- Guide Operations in determining root cause of discrepancies and the development of corrective actions, verification activities.
- Make suggestions on quality improvements
- Maintain communication with QA Supervisor/Manager supplying reports as requested.
- Maintain the facility programs to ensure that GMP compliance is managed.
- Oversee the Product Destruction process to ensure compliance with all regulatory and SOPs. This includes monitoring outbound destruction orders and managing all required destruction documentation.
- Key functions for this role is managing storage conditions, vendor qualification, product temperature monitoring, testing and managing Lot recalls.
- Inventory reconciliation duties may be assigned which will include counting, verification, documentation and signoffs
Performing research to determine reason and corrective action for operational overages and/or shortages in Pick, Pack, Labeling or any other operational process.
- Conduct investigations, problem solving, and resolution of compliance issues
- Train operations, client services, staff, IT, and other groups on compliance topics/procedures
- Provide clarification and interpretation on existing procedures.
- Attend operations meetings to maintain knowledge of the business
- Maintain knowledge of current regulatory issues, operational direction, and strategy
- Perform corrective action for deviations
- Coordinate release of quarantined inventory
Document and Procedures Management
- Train internal client on SOPs, work instructions, and other regulatory topics
- Implement and manage training programs and materials
Safety, Sanitation, Security
- Maintain exceptional work environments that allow for impromptu client inspections, potential client tours and ensure image of Priority Solutions as an industry leader.
- Security and safety standards must be followed, with zero tolerance for deviation.
- Operate all equipment and obtain necessary certifications according to OSHA, security and safety standards established.
Education/ Experience (BMQ):
- Associate's Degree
- One to three years of work in a FDA/DEA related business. Demonstrable capability in conducting and understanding quality systems, performing audits, and writing and revising SOPs. Experience in working effectively with limited supervision is also important. Ideally, inclusive of interface with state and federal agencies.