Job Description

POSITION: QC Coordinator
Job Posting Number: 07-22
REPORTS TO: Quality Supervisor
Posting Date: 4 March 22
No. Of Vacancies: One (1)
Closing Date: 10 March 22 4pm

1. OVERALL RESPONSIBILITIES:
The QC Coordinator will follow current Good Laboratory Practices (cGLP) and support QC laboratory systems to ensure the chemical and microbiological integrity of all raw materials and finished products as defined by their respective specifications. Accountable for timely coordination of QC functions including releasing raw materials and finished product CofAs to meet production scheduling requirements and customer deadlines. Maintain Labware functions including lot creation, specification creation and handling of OOS.

2. DUTIES AND RESPONSIBILITIES
• Coordinate and maintain all QC & laboratory systems, cGLP systems and support overall Quality Team.
• Back up to QC Technician/Sampler job duties as required.
• Coordinate lab functions to meet production scheduling requirements and customer due dates for releasing raw materials and finished product CofAs.
• Responsible for timely receipts of all Raw Materials and Labware lot creation for Samplers.
• Conduct RM documentation testing including Supplier CofA Verifications and Certified Documentation tests.
• Complete RD receipts, issue SAM# and maintain RD inventory in QCLIMS.
• Log samples and set up testing in Labware for investigation samples, resampling for OOS, FP reworks and any ‘ad hoc’ sample/testing requests.
• Create sample requests via Sharepoint for QC support as required.
• Create FP lots in Labware and maintain FP Labware sample label system via PSS/PLS issued.
• Responsible for all RM releases in Labware and QAD and all FP CofA releases in Labware.
• Print release or status labels and RD material labels for RM containers.
• Responsible to track raw material retest/expiry date program, initiate re-testing as required and attend required meetings on MRB/HOLD/REJECT status updates. Initiate Rejection Trackers, as required.
• Complete QC deviations including warehouse damage deviations as required.
• Responsible for handling and coordinating all INTL site Out of Specifications (OOS) including completing OOS reports in Labware, OOS deviations and providing Q10 status updates.
• Review all INTL QC logs, lab documentation, notebooks and Labware ELN.
• Complete Mineral oil/Lecithin and other RM blend batch record reviews including Gel Melt batch record reviews as required.
• Conduct Formal sample AQLs as required.
• Complete first review on RMQ packages as required.
• Create and prepare Labware raw material specifications (RMAs) from RMQ documents and finished product specifications from PSS/PLS. Complete all Change Requests for specification revisions.
• Lead projects for major specification updates including supplier follow ups for spec alignment, as required.
• Prepare RD specifications (ie. RMSG, RMLQ, SG, PL) in Labware as required.
• Coordinate Environmental Monitoring Program including review of monthly reports, entering data and trending.
• Review and trend Purified Water System testing data weekly.
• Perform production batch potency adjustments.
• Maintain system of tracking lab supply purchases and order lab supplies monthly as required.
• Review internal and external calibration data and reports, as required.
• Fulfill retain and QC document requests as required.
• Assist with quality audits and technical tours of the INTL laboratory.
• Complete plantwide Daily Inspections on a rotational basis.
• Prepare and revise QC SOPs as required.
• Prepare yearly Trend Reports for EM, PWS and OOS.
• Prepare Technical Documents and Study Protocols and special projects as required.
• Other duties and assignments as required.

3. QUALIFICATIONS AND BEHAVIORAL REQUIREMENTS:
• Minimum Technical Diploma in Science related field from an accredited post-secondary institution
• Minimum 2 years laboratory practical experience in a pharmaceutical, nutritional, food or health products manufacturing laboratory environment
• Comprehensive knowledge of laboratory systems and cGLP
• Familiar with USP, AOAC, FCC and other standards or compendia used in the food and drug industry
• Experience in softgel manufacturing environment an asset
• Excellent communication skills and report writing
• Excellent problem solving skills
• Proficient with computers
• Experience with manufacturing and inventory management software, LIMS software systems, and other Quality System database systems an asset
• Team oriented focus
• Self-starter and critical thinker
• High work ethic standards a must
• Ability to work with minimal supervision
• Able to work shift work for job coverage as required.
• Able to work overtime when workload volume is high and to complete special projects as required
• Must have own transportation to transport samples to Rhodes site for lab testing (back up to sampler) as required

How to Apply

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: Not Disclosed.

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