Position Responsibilities:
QUALITY ASSURANCE / DOCUMENTATION:
General Quality Assurance
1. Act as lead supervisor in ensuring the day-to-day center activities of quality operations are compliant with SOPs and applicable federal and local regulations as well as Human Ressources policies.
2. Manage creation, review and/or revision and implementation of all documentation related to the local Quality Department, including but not limited to SOP/APP, reports, records, test results, and equipment logbooks. Assist Head Office Quality department in reviewing central documentation like SOPs/APPs, policies, or manuals.
3. Ensure that all center specific staff perform routine tasks according to most current applicable SOPs/APPs through direct observation and/or review of documentation (logbooks, log sheets, training records, etc).
4. Identify potential SOPs revisions as needed to support continuous improvement.
5. Manage creation, coordination and application of change control procedures.
6. Perform reviews on lookback information, waste shipment, and operational records to ensure they are complete, accurate, and compliant with the current GMP requirements.
7. Ensure that equipment is qualified, maintained and calibrated properly. Review and verify repair documentation is complete and approve equipment for return to service.
8. Manage review of equipment logbooks on a monthly basis.
9. Manage collection and analysis of data for trending analysis (including but not limited to deviation reports, exposure reports, and post-donation reports) and design appropriate action plans to correct negative trends.
10. Ensure the Donor Center’s licenses and certificates are in-date and valid.
11. Stay current with federal, provincial, local, and company-specific rules, regulations, and practices. Maintain a high level of working knowledge for national and international laws, regulations and standards.
12. Ensure plasma unit shipments are prepared and performed as per provincial and national standards and as per customers’ specifications.
Deviations/ Non conformances
13. Manage tracking of deviations in Standard Operating Procedures and Policies through established mechanisms. May stop operations or shipments when donor or product safety is or may be compromised.
14. Ensure deviation investigations are handled appropriately and actions completed to facilitate closure within required timelines.
15. Manage evaluation of effectiveness of corrective actions plans taken for designated deviations.
16. Report errors, deficiencies, discrepancies, and observations on a regular basis to Quality & Regulatory Affairs Director.
Auditing
17. Conduct regular internal audits of the Plasma Center for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program. Manage preparation of Non-conformance reports and necessary effective action plans to be taken.
18. Conduct/participate in external audits as required.
19. Assist in authorities or customers external audits.
20. Ensure the plasma center is “inspection ready” at all times by managing adherence to SOPs, compliance policies, and the quality system through utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Manage preparation of regular reports to center, area and corporate quality management department as to the state of quality and systems at the center.
TRAINING:
- Review and assist with local center new staff hiring process.
- Manage training of local center new staff on the company SOPs and Policies.
- Manage and coordinate training of ongoing staff (center-specific or from other CPR centers), as required, on new Standard Operating Procedures (SOPs) and Appendices (APP), SOP/APP revisions, corrective and preventive actions.
24. Train Quality Systems Associates (center specific or from other Grifols centers), as required, in all aspects of their function, including Good Manufacturing Practice (GMP) principles, adherence to procedures and protocols, and any software/hardware that is necessary to complete their duties.
25. Train other Grifols Quality Systems Managers, as required, in all aspects of their function, including Good Manufacturing Practice (GMP) principles, adherence to procedures and protocols, and any software/hardware that is necessary to complete their duties.
- Manage and coordinate training of other designated staff, as required, in performing functions related to quality assurance.
- Verify that all center specific employees training is complete, documented properly and archived correctly.
28. Communicate changes and updates to the quality standards and regulations with all plasma center’s staff and monitoring all required retraining processes.
QUALITY CONTROL:
- Manage monitoring and report printing of Environmental Monitoring System on a weekly basis.
30. Ensure that all procedures related to the production of plasma unit comply with the quality standards and national and international regulations.
31. Perform all product release activities and generate appropriate reports.
32. Perform reviews of the documentation of unsuitable test results and the disposition of the associated units.
33. Manage inspection of incoming materials and reporting of any supplies that have not met quality specifications and requirements prior to use, and perform QC release on the softgoods that pass inspection.
- Ensure that proficiency testing processes are completed properly and according to required timelines, graded results are evaluated, and failing results are investigated through the Deviation Management process.
OTHER:
35. Directly manage Quality Systems Associates and conduct performance reviews periodically to ensure that they are performing their job according to the required standards.
36. Coordinate and facilitate management review meetings and participates in center staff meetings.
37. Support the center management team in identifying operational opportunities for continuous improvement, initiate changes to center processes as needed, through use of company approved procedures
38. Perform other duties as required.
39. Responsible for maintaining a consistent, regular attendance record.
- May be required to work weekends, evenings, and some holidays.
41. This job may require a 5% travel.
NOTE: This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Job Types: Full-time, Permanent
Pay: $56,160.00 per year
Benefits:
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
Work Location: In person
