Senior Quality Assurance Coordinator
Lynden International Logistics ULC is looking for a Senior QA Coordinator / APIC who will be responsible for ensuring Company compliance to the Canadian Good Manufacturing Practices, Canadian Food Inspection Agency and any other relevant Health Canada Acts and Regulations at the Lynden International Logistics ULC Calgary branch. The Senior QA Coordinator / AQPIC will provide guidance to the site QA Coordinators and provide coverage for the QPIC when required.
We encourage our employees to grow and develop within the company and believe our diverse workforce contributes tremendously to our success. Lynden offers many benefits for full-time employees including: Medical, Dental and Vision Insurance; an Employee Assistance Program; and Retirement Plans.
WORKING SCHEDULE: Monday to Friday, 9:00am - 5:30pm
REPORTING TO: Director of Regulator Affairs & Quality Assurance
DUTIES & RESPONSIBILITIES:
- Working closely with the Director of RA & QA will provide guidance and support to site QA Coordinators ensuring quality assurance tasks are properly executed and completed on time.
- Train QA Coordinators and ensure branch training program for all staff is maintained.
- Arrange for implementation of new and updated procedures with QA and warehouse staff. Advise Director of RA & QA of implementation or ongoing compliance issues.
- Working with external consultants ensure validation projects are carried out as planned and reports are completed and approved.
- Ensure quality Deviations are reported to clients where applicable, incidents are investigated and reports are completed on time. Ensure Corrective and Preventative actions for Root Cause are developed and implemented.
- Working with the Distribution Manager ensure Change Controls are initiated on time, action items are adequately documented and closed as appropriate.
- Ensure market complaints for product quality are properly documented and reported to the client manufacturer.
- Provide oversite of recall activities as outlined in the Lynden recall procedure.
- Monitor GMP activities at the branch, document and report problems to Operations management and Director of RA & QA.
- Ensure instrument calibrations are completed as required.
- Ensure Temperature records are reviewed as required.
- Ensure equipment maintenance records are being maintained. Notify Operations management if maintenance checks are not being performed on time or service records are not available from the contractor.
- Participate and provide input to inter branch QA call meetings.
- Manage external inspections, provide audit responses and liaise with clients for quality assurance activities.
- Review and provide branch approvals for Standard Operating Procedures and Client Procedure Manuals and serves as signatory to procedures at the branch.
- Ensure the QA group’s chargeable hours are tracked and reported.
- Carry out other tasks as assigned by Director RA & QA.
- Provide back up to QA coordinators in their absence or unusual level of activity.
- Provide back up to QPIC in their absence.
SKILLS AND TRAINING REQUIRED:
- Detailed knowledge of Good Manufacturing Practices, Guidelines for the Temperature Control of Drug Products during Storage and Transportation and Health of Animals Regulations.
- Excellent organizational and analytical skills to manage workload and investigate quality incidents for root cause
- Excellent interpersonal skills for and working with internal staff and clients
- Attention to detail and accuracy
EDUCATION AND EXPERIENCE REQUIRED:
Minimum education required:
Bachelor Science obtained at a Canadian university (or confirmed equivalency)
Post graduate programs and certification in Quality Assurance is desirable
Minimum experience required:
Two or more years of quality assurance work experience in pharmaceuticals
Lynden International Logistics ULC is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Accommodation will be provided in all stages of the hiring process. Contact us for any accommodation requests, and we will work with you to meet your needs.
- Pay Type Salary
- 4441 76 Ave SE suite 1, Calgary, AB T2C 2G8, Canada