QUALITY ASSURANCE ASSOCIATE – ON THE FLOOR AND PRODUCT RELEASE
📍 Location: Stouffville, Ontario
⏰ Shift: 10:00 PM – 6:30 AM EST
📅 Schedule: Monday – Friday
💰 Pay Rate: Up to $40/hr (based on experience)
⏳ Duration: 12 Months
🔄 Employment Type: Temp to Perm (Contingent)
ABOUT THE ROLE
As a Quality Assurance Associate – On the Floor and Product Release, you will provide critical support to operations by performing quality review of executed manufacturing/packaging/testing batch records, ensuring the correctness, accuracy and completeness of information. You will perform timely release of bulk/packaged finished goods, including release to international markets and private label customers.
You will also provide quality oversight and support in the evaluation of quality floor incidents, which includes completing the Deviation Investigation Form (DIF), review and approval of Work Orders, review of change controls, electronic data review and performing trend analysis for walkthroughs and work orders. You will perform sampling of water and environmental monitoring, annual schedule, daily walkthroughs, review of log books, daily spot checks on the BAS, reviewing BAS acknowledgements and evaluating BAS incidents.
HOW YOU'LL SPEND YOUR DAY
- Audit of executed manufacturing/packaging/testing batch records and release of bulk/finished goods in as close to real time as possible ensuring GMP and SOP compliance including electronic data review.
- Complete QA final identification sample, prepare accurate, clear and logical audit notices and maintain audit metrics.
- Provide quality oversight and support in the evaluation of quality floor incidents, which includes completing the Deviation Investigation Form (DIF), review and approval of Work Orders, review and approval of PSS comments, review of change controls, electronic data review and performing trend analysis for walkthroughs and work orders.
- Lead and work collaboratively with site operations in the resolution of quality incidents and deviations by completing the DIF and determining product impact, root cause and applicable CAPAs to ensure compliance with GMPs and SOPs.
- Perform additional documentation audits/reviews and internal plant GMP audits such as logbook auditing, periodic trend analysis, BAS acknowledgement comments, Work Orders and evaluations.
- Perform sampling of water and environmental monitoring, annual sampling schedule preparation daily walkthroughs, review of log books, daily spot checks on the BAS, reviewing BAS acknowledgements and evaluating BAS incidents and periodic trend reports.
- Perform AQL evaluations including issuance, verification and evaluation and assist in the sampling and tagging of packaging material, bulk or finished products when required.
- Work collaboratively with site operations and QA in the resolution of GDP/GMP deviations to ensure compliance with GMP and SOPs.
- Respond to quality incidents as required.
- Support retention sample area if applicable.
- Liaise with Planning, Operations, Validation, Technical Operations, QC, Regulatory Affairs, Compliance and other QA teams to obtain necessary information/documentation required for product review/release to meet MPS schedule.
- Support in minor deviations, complaints, CAPA's, CAPA ERs as and when required.
- Prepare a daily quality shift report and communicate with internal and external stakeholders on any queries related to batch release documentation.
YOUR SKILLS AND EXPERIENCE
- Education: Hold a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.
- Experience: One (1) year of relevant Quality Assurance experience. Preferred: Three (3) years of relevant Quality Assurance experience.
- Technical Skills: Must be computer literate with good working knowledge of TrackWise, Oracle and/or SAP ERP systems, LIMS and MS Office suite (Excel and Word).
- Regulatory Knowledge: Good working knowledge of SOPs, GMPs applicable to Quality Operations, Quality Control, Manufacturing and Packaging. Understanding of Good Documentation Practices (including Data Integrity).
- Technical Aptitude: This position requires a mechanical aptitude to understand manufacturing, packaging and quality control testing operations as well as the mechanical aspects of the plant.
- Communication: Ability to clearly and logically explain ideas in a concise and organized manner with the use of proper grammar.
- Organization: High organizational skills used to set and manage priorities, handle multiple tasks in a timely manner, and ability to consistently evaluate work processes and outcomes.
- Problem Solving: Must demonstrate ability to solve moderately complex problems and analyze and apply appropriate solutions.
- Analytical Skills: Ability to perform intermediate computations for quantitative data analysis.
- Collaboration: Be able to communicate effectively with cross-functional departments to resolve quality incidents or GMP infractions in a timely manner.
- Flexibility: Travel between sites (on an as needed basis).
Use AI for Hiring: Our recruitment process for this role includes the use of AI-based tools to help evaluate candidate qualifications and screen applications.
Why Kelly?
At Kelly®, we’re committed to finding rewarding opportunities that help you thrive - both professionally and personally. We partner with leading organizations across industries, connecting talented individuals to roles that fit their skills, interests, and goals. As part of the Kelly team, you’ll have access to a diverse network, ongoing career support, and resources to help you succeed. We value inclusion, respect, and work-life balance, and we offer competitive pay and benefits. Join us and discover what’s next for your career!
