Coordinator, QC Environmental Monitoring

Job Summary

Responsible for ensuring that Environmental sampling and trending are performed and documented according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), established Standard Operating Procedures (SOP), and regulatory requirements. This includes responsibility for assigning tasks to EM microbiologists.

Have sound understanding of regulatory requirements and standards (FDA, EU, ICH, ISO, USP).

The Microbiologist QS8 will act as a Qualified Trainer, LIMs support and Lead investigator for the Microbiology department and will be responsible for providing front line support in Training, writing reports, compliance audit, Protocol writing and execution.

Job Responsibilities

1. Schedule and co-ordinate daily operations of the QC Environmental Monitoring (EM) Group.
2. Review results on appropriate documentation (or in LIMS) for all EM or any tests processed by the Third party Laboratory.
3. Performs and coordinates the monitoring of manufacturing environments and critical utility services across all GTA sites, to ensure compliance with the approved standards.
4. Executes the evaluation of new materials for EM sample collection.
5. Prepare trend reports as required, creates STR projects, EM sampling protocols, Cleanliness reports and EM studies.
6. Provides front line support in preparation for internal, customer and regulatory audits. Provide assistance during audits/ inspections as Subject Matter Expert.
7. Co-ordinate with Validation Services in qualifying new or remodelled production suites, water systems and critical utility services.
8. Reviews and optimises processes and procedures on a periodic basis to maximise efficiency.
9. Promote safe work environment in team and assist management to resolve any safety related issue.
10. Performs the release of Purified water lots (usage decision) and approves the CofA in LIMS.
11. Initiates investigation and act as a lead investigator or assist Supervisor when investigating OOT or OOS results, to determine the most probable root cause and appropriate correction actions (CAPA).
12. Performs troubleshooting of Environmental sampling/monitoring problems and makes recommendations for solutions in consultation with supervisor and manager.
13. Liaises with Internal and Third Party Laboratories to ensure the proper and timely testing of EM and Water samples.
14. Reviews and approve EM and Water samples in LIMS and ensures that the LIMS data is in compliance with the current approved procedures. Performs the LIMS Supervisors tasks in LIMS, when required.
15. Liaise with the Building Services Department on any issues related to results of monitoring the Water system.
16. Analyses EM data of Surface, Ambient air, Compressed gas and Water samples from all facilities and evaluate the Action and Alert Limit as required.
17. Coordinates with Laboratory Technical Services department for calibration, qualification and maintenance of all applicable EM equipments.
18. Co-ordinate and assist with any special EM sampling and testing requests with Production, Packaging, Engineering/Maintenance, QC Chemistry, Microbiology and Third Party Laboratories.
19. Lead and provide support in the initiation of Change Control Requests (CCR's) to revise work instructions and/or create new EM procedures.
20. Provides the training to new and existing team members on related EM techniques and cGMP and maintain the training records.
21. Performs all work in support of Apotex values of Perseverance, Collaboration, Courage and Passion.
22. Maintains positive working relations with all internal and external customers.
23. Works as a key member of a team to achieve all outcomes.
24. Acts as a designate of the EM Supervisor, in their absence.
25. Performs other duties as assigned.

Job Requirements

• Education
  • Bachelor of Science Degree/Community College Diploma (or equivalent) in a related discipline.

• Knowledge, Skills and Abilities
  • Good knowledge of microbiological techniques including aseptic technique
  • Strong communication skills in English language with good technical writing skills.
  • Strong organizational, interpersonal and time management skills
  • Detail-oriented, accurate,reliable and able to work independently with minimal supervision
  • Ability to follow instructions according to written procedures and the ability to supervise others
  • Ability to manage multiple priorities in a fast-paced and changing environment
  • Strong understanding and utilization of current GMP and GLP
  • Computer skills with experience in SAP, Trackwise and LIMS is preferred.
  • Job will involve shift rotations, Evening or Night shift with weekend coverage and working on different sites as required.

• Experience
  • Minimum five years experience in Microbiology Laboratory/Environmental Monitoring in a Pharmaceutical environment.