North York, Ontario

Coordinator – Cleaning Sampling

Coordinator (Cleaning sampling activities)
Pharmaceutical
Toronto

Major Activities of the Job:

Coordinate sample receipt, examination and log-in of test samples, stability samples and retention samples.

  • Ensure chain of custody is maintained between customer and quality control.
  • Co-ordinate the receipt and examination of all samples entering quality control (i.e. test samples including receipt of internal samples, inter-site samples).
  • Verify that all samples, sample labels and associated documentation (where applicable) meet with Divisional and Departmental requirements for compliance.
  • Communicate with customers to ensure compliance of labelling and associated documentation. Identify issues of non-compliance to the area Manager / designee and facilitate resolution of issues.
  • Log-in (manually or electronically) all samples and ensure samples are stored appropriately, in accordance with Divisional and Departmental SOPs.

Distribute samples to laboratories for testing, ensuring chain of custody and proper transport.

  • Coordinate the distribution of test samples and associated documentation to the QC testing laboratories.
  • Ensure chain of custody is maintained between the sample management area and the QC testing laboratory.
  • Ensure samples are maintained at appropriate temperatures during transport and are placed in appropriate storage locations in the QC testing laboratory.

Assist in cleaning verification/validation activities as required.

  • Maintain inventory control of cleaning validation samples.
  • Assist in the pulling of cleaning validation samples and sending them to the QC testing laboratories with the BRD Department. Samples are pulled in accordance with internal protocols / schedules.
  • Coordinate the disposal of cleaning validation samples with the BRD Department.
  • Sample Handling for scheduled pulls and sample pulls (LIMS) repeat/retest requests, sample set up and disposition upon completion of study.
  • Preparation of Process Orders for cleaning validation programs. Input and maintenance of the BRD forecast in the SAP.

Complete the daily operations associated to the maintenance of the sample management area and temperature controlled storage units.

  • Perform daily monitoring of the temperature-controlled storage units and associated chart recorders (sample management area, cleaning validation samples, and retention sample storage units).
  • Initiate an event and assist in the investigation of any temperature deviations.
  • Coordinate the movement of samples to appropriate storage locations in the event of an extended temperature deviation of a storage unit.
  • Change temperature charts in accordance with departmental SOPs, file and retain charts appropriately.
  • Ensure sample management area and all storage units are properly maintained and required cleaning, calibration, and maintenance are performed according to schedule.

Maintain the documentation associated to the sample management area (i.e. SOPs, logbooks, etc.)

  • Perform SOP writing and revisions as required.
  • Maintain SOPs for the Sample Management Department and ensure they are up-to-date.
  • Maintain all logbooks in accordance with departmental SOPs and ensure they are retained properly.
  • Perform filing and administrative duties for the Sample Management area.
  • Generate required reports and distribute to appropriate departments in accordance with departmental SOPs.

Minimum Qualifications:

  • Minimum three (3) years Bachelor’s Degree (Biology/Microbiology), plus a minimum two (2) years of previous relevant work experience.
  • Working knowledge in the following areas: cGMP, Sample handling and Product/Test knowledge
  • Strong Computer skills
  • Excellent Interpersonal and Communication skills
  • Ability to work independently and as a part of a team
  • Ability to effectively manage one's time along with strong organizational skills
  • Ability to identify and troubleshoot problems in a timely manner