Quality Assurance Coordinator - Halton Hills, Canada - Lynden Incorporated
Description
Overview:
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.
Responsibilities:
DUTIES & RESPONSIBILITIES:
- 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 followup to ensure actions are completed and documented.
- Provide feedback and assistance to Customer/Client questions and concerns.
- 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. Monitor controlled substances management and reporting.
- 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 followup.
- 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.
- 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.
- On call 24 hours per day 7 days a week for emergencies.
- Supervise and approve packaging / labeling operations that are conducted at the branch.
- Cover for other QA coordinators' duties and perform other activities as assigned by senior QA coordinator or senior management.
Qualifications:
SKILLS/TRAINING REQUIRED:
(details of course training requirements are outlined in the Learning Management System)
- Strong knowledge of current regulatory requirements
- Superior familiarity with warehouse and office operations
- Effective problem solving skills
- Excellent verbal and written communication
- Excellent organizational skills
- Ability to make decisions and recommendations
- Demonstrate effective interpersonal and team skills
EDUCATION & EXPERIENCE:
Minimum education required:
B.Sc. degree or equivalent
Minimum experience required: 2 years warehouse operations experience
Plus 6 months on-the-job training OR equivalent combination of experience and education.
SUPERVISORY RESPONSIBILITY:
Provision of direction to a unit: With limited authority, directs work of a group of employees within a unit, with responsibility for assigned work, checking results, training and appraising staff or making recommendations thereon.
MEASURABLE PERFORMANCE STANDARDS:
- Quality of service provided to clients and their customers
- Ability to meet deadlines
- Adherence to procedures
- Organization and completeness of records
- Communications with other departments
DESCRIPTION OF WORKING CONDITIONS:
Works under office and warehouse conditions.
Some overtime as required.
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