We are looking for a highly motivated and energetic professional to join our team as a QA Compliance Analyst in Brantford, ON.
Compensation
The annual salary range is $50,000–$65,000, depending on qualifications and experience.
Responsibilities
Develop, implement, and maintain departmental procedures, analytical test methods, and quality systems in compliance with GMP and applicable regulatory requirements.
Oversee daily Quality Assurance and Quality Control operations, including staff supervision, training, work assignments, performance management, and departmental budgeting.
Manage quality compliance programs, including Change Control, Deviations, CAPA, internal audits, and supplier audits.
Oversee final product release, product recalls, returns, customer complaints, and approval of analytical methods, SOPs, and controlled documents.
Ensure regulatory compliance, coordinate regulatory audits, prepare audit responses, and maintain effective calibration and preventive maintenance programs.
Requirements
Bachelor’s degree in Chemistry
Bachelor’s degree in Microbiology
Bachelor’s degree in a related scientific discipline
Support other team members in developing, maintaining, and preparing reliable cleaning processes for product- and indirect-product contact parts to meet future requirements.
Responsibilities
Support the development and validation of cleaning processes for new products.
Support the development and validation of improved cleaning processes for existing products.
Support the development and implementation of new strategies for cleaning validation.
Support the creation of documents for cleaning validation activities (protocols, reports, risk assessments, SOPs).
Coordinate cleaning validation activities with other departments.
Project Manager to lead and manage projects in the aseptic areas, particularly in the development, validation, and FDA submission processes for pharmaceutical and medical device products.
Responsibilities
Develop project timelines, resource allocation plans, and budgets, ensuring timely and on-budget delivery.
Coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.
Lead and manage complex projects related to the development, commissioning, process development and validation of aseptic pharmaceutical or medical device products.
Ensure compliance with FDA and other regulatory bodies’ requirements, particularly in aseptic areas and sterile manufacturing processes.
Prepare and review documentation for FDA submissions and other regulatory filings.
Requirements
Bachelor’s degree in Engineering, Life Sciences, or a related field (Master's degree preferred)
Lead and coordinate validation activities for manufacturing processes, equipment, and cleaning systems while driving operational excellence initiatives.
Responsibilities
Design and execute process, equipment, and cleaning validation programs.
Develop validation protocols, reports, and supporting documentation.
Review and assess technical transfer and site-transfer documentation.
Perform risk assessments using recognized methodologies such as FMECA.
Analyze validation data and provide recommendations based on results.
Requirements
Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Process Technology, Life Sciences, or a related discipline.
The Hygienist is the site owner of hygiene and sanitation effectiveness, responsible for preventing contamination, leading investigations, and driving sanitation program ownership on the production floor.
Compensation
The pay range for prospective employees in this role is between $77,000 and $91,000 per year
Responsibilities
Own the site sanitation program, including SSOPs, master sanitation schedule, deep-clean plans, and cleaning procedures
Serve as site subject matter expert for sanitation chemistry
Define and verify CIP and COP parameters and act on deviations
Drive dry and low-water cleaning practices and control cleaning tools
Perform pre-operational and post-sanitation inspections on all shifts
Requirements
Bachelor’s degree in Food Science, Food Microbiology, Microbiology, Biology, Dairy Science, Food Engineering, Chemical Engineering, or a related scientific discipline
HACCP certification (required)
Nice to have: PCQI certification
Nice to have: Training in GFSI schemes (SQF, BRC, FSSC 22000)
Accountable for the quality and compliance performance of assigned Third Party Manufacturers (TPMs), ensuring compliance with applicable regulations, cGMP requirements, Abbott Global/Regional Policies, and Quality Technical Agreements (QTAs).
Compensation
The base pay for this position is N/A
Responsibilities
Ensure compliance with cGMP and regulatory requirements
Manage quality risk activities including deviations, investigations, change controls, CAPAs, and product complaints
Review and approve TPMs quality documentation
Lead quality oversight through performance monitoring, GEMBA visits, and continuous improvement initiatives
A Validation Engineer ensuring manufacturing facilities, equipment, and processes meet the highest quality and compliance standards.
Responsibilities
Develop and maintain Validation Master Plans across our manufacturing areas.
Plan, execute and maintain validation activities and documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process and Cleaning Validation.
Analyse test results to confirm equipment, systems and processes meet defined validation and acceptance requirements.
Support the commissioning and validation of new facilities, equipment and systems, as well as changes to existing manufacturing operations.
Maintain the validated state of our GMP manufacturing facilities, systems and utilities.
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