Quality Assurance Coordinator/AQPIC

POSITION DESCRIPTION:

This position is required to monitor the overall status of the branch from a Quality perspective. Compliance to regulations, including cGMP’s, will be maintained through the implementation of procedures and training, and regular inspections. Responsible for the day to day operations of the Narcotic department 

DUTIES & RESPONSIBILITIES:

Quality Assurance Coordinator

• Ensure all staff are trained in their respective job functions, including GMP training and maintain training records
• Write and revise standard operating procedures as necessary.
• Coordinate maintenance of procedure manuals at the branch.
• Conduct regular inspections of the facility and report the findings to the Branch Manager and senior management.
• Respond to audits, develop action plans and provide follow-up to ensure actions are completed and documented.
• Provide feedback and assistance to Customer/Client questions and concerns.
• Initiation and completion of Deviation Reports and Change Controls
• Monitor the processes and systems within the branch to promote effective operation and procedural compliance. Ensure documentation is complete and accurate.
• Maintain relations with outside contractors/suppliers and monitor effectiveness of their services.
• Provide assistance with inventory reporting and lot control.
• Recalls – Working directly with the Client ensure product is both physically and systemically quarantined
• Supervise lot hold/release processes to ensure effective control and accurate documentation
• Investigate discrepancies and problems, and advise the appropriate individuals of the findings through effective reporting and follow-up.
• Maintain ongoing surveillance/reporting of temperature conditions within the different storage areas of the warehouse.
• Perform temperature alarm testing and security testing.
• Coordinate regular and emergency maintenance of equipment.
• Place product on “Short Dated Hold” as per Client Procedure Manuals and physically remove product from primary picking locations
• Coordinate disposition of product as per Clients requests and Lynden’s Destruction agreement.
• Perform specific duties for inbound receipts as agreed upon in the Client Procedural Manuals.
• Develop proactive strategies for preventing possible future problems with systems or processes.
• Maintain communication with all levels of the branch by attending meetings with management and staff and provide input and training.
• Cover for other QA coordinators' duties and perform other activities as assigned by the Director of RA & QA.

AQPIC

•             Picking orders for shipment against verified legal signatures.

•             Entering product receipts into inventory.

•             Checking reports on a daily and monthly basis for accuracy. Sending appropriate reports to the Drug Control Unit.

•             Checking and monitoring inventory levels for discrepancies and/or potential back orders.

•             Authorizing and checking returns and entering them into inventory.

•             Dealing with customer and client questions and/or concerns.

•             Communicating with the appropriate Health Canada officials regarding regulatory affairs, loss-reporting.

•             Maintaining the security of the overall caged area including the vaults.

• Checking orders and routing through agile system

•             Co-ordinate narcotic destructions

SKILLS/TRAINING REQUIRED:

• Strong knowledge of current regulatory requirements
• Superior familiarity with warehouse and office operations
• Effective problem solving skills
• High work standards
• Excellent verbal and written communication
• Excellent organizational and time management skills
• Ability to make decisions and recommendations
• Demonstrate effective interpersonal and team skills

EDUCATION REQUIRED:

Minimum education required:

              B.Sc. degree or equivalent

Minimum experience required:

              2 - 3 years related work experience

Plus 6 months on-the-job training OR equivalent combination of experience and education.