Validation Specialist (Quality Assurance)

Bio Agri Mix, LP

Mitchell

Sur place

CAD 55 000 - 65 000

Plein temps

Il y a 9 jours

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Avantages offerts par ce poste

Health benefits after probation
Group RSP Plan after probation
Holiday bonus

Résumé du poste

Bio Agri Mix LP in Mitchell, Ontario, seeks a Validation Specialist (Quality Assurance) to coordinate validation activities across manufacturing and laboratory operations, ensuring compliance with Health Canada, FDA, and HACCP standards.

The role focuses on process and cleaning validation, review of batch records, CAPA implementation, and participation in audits; the ideal candidate has 1–2 years in pharma or food quality and a BSc or MSc.

Qualifications

  • 1–2 years of experience in a pharmaceutical or related industry.

Responsabilités

  • Develop protocols for process and cleaning validation studies aligned with cGMP and internal SOPs.
  • Coordinate and oversee validation activities on-site.
  • Review manufacturing batch records and lab documentation for compliance.
  • Approve Quality Control test results, data sheets, and Certificates of Analysis.
  • Investigate deviations, non-conformances, and out-of-specification results; implement CAPAs.
  • Analyze validation data and compile comprehensive reports.
  • Participate in GMP inspections and internal audits.
  • Assist in updating the Master Validation Plan annually.

Connaissances

statistical analysis tools
analytical testing methods
strong communication
organizational skills
Microsoft Office

Formation

B.Sc. or MSc in Chemistry/Biological/Pharmaceutical Chemistry or related field

Description du poste

Validation Specialist (Quality Assurance)

Validation Specialist (Quality Assurance) – Full-Time, Day Shift

Company Overview

Bio Agri Mix LP has been a trusted Canadian manufacturer of animal feed medicants and veterinary health products for over 40 years. Headquartered in Mitchell, Ontario—a rural community in Perth County near Stratford and centrally located to London and Kitchener, we are a Health Canada licensed, FDA approved, and HACCP certified facility.

We are currently seeking an ambitious and detail-oriented individual to fill an open position on our Quality Assurance team as a Validation Specialist.

Position Overview

As a Validation Specialist, you will be responsible for coordinating validation activities related to manufacturing processes, laboratory operations, and regulatory requirements. You will ensure compliance with quality standards and regulatory frameworks, including Health Canada, FDA, and HACCP requirements. This role is critical to maintaining our commitment to product quality, regulatory compliance, and continuous improvement across the organization.

The ideal candidate will have experience with process and cleaning validation within a manufacturing environment, preferably in the pharmaceutical or food industry.

  • Salary Range: $55,000 – $65,000 per annum. Salary will be commensurate with knowledge and related experience.
  • Health Benefits: Eligible after a successful 90 day probation period
  • Group RSP Plan: Eligible after a successful 90 day probation period
  • Holiday Bonus: $1,000 (pro-rated based on start date and active days worked)
Work Schedule
  • Day Shift: Monday to Thursday | 8:00 AM – 4:30 PM | and Friday 8:00 AM – 4 PM
Work Arrangement

On-site position — reliable daily commuting or relocation prior to starting is required.

Please note: Housing availability in the Mitchell area is limited. Candidates considering relocation are encouraged to plan accordingly.

Key Responsibilities
  • Develop protocols for process and cleaning validation studies aligned with cGMP and internal SOPs
  • Coordinate and oversee validation activities on-site
  • Review manufacturing batch records and lab documentation for compliance
  • Approve Quality Control test results, data sheets, and Certificates of Analysis
  • Investigate deviations, non-conformances, and out-of-specification results; implement CAPAs
  • Analyze validation data and compile comprehensive reports
  • Evaluate proposed changes for regulatory/validation impacts
  • Participate in GMP inspections and internal audits
  • Maintain organized records and documentation
  • Support SOP updates and continuous quality system improvement initiatives
  • Assist in updating the Master Validation Plan annually
Qualifications
  • Education: B.Sc. or M.Sc. in Chemistry, Biological/Pharmaceutical Chemistry, Biology, or a related field
  • Experience: 1–2 years of experience in a similar role in the pharmaceutical or related industry
  • Certification: HACCP certification is an asset
  • Knowledge Of: cGMP, HACCP, and Validation Protocols
Skills
  • Experience with statistical analysis tools and analytical testing methods
  • Strong communication, critical thinking, and organizational skills
  • Ability to work independently and in a team environment
  • Proficient in Microsoft Office (Excel, Word, Outlook)
  • Excellent attention to detail and a strong work ethic
  • Positive attitude and willingness to contribute to team success

If you are interested in a career with a reliable employer in the animal health industry and meet the requirements, we encourage you to submit your resume for consideration.

Please apply only if you:
  • Applicants must be legally entitled to work in Canada (e.g., Canadian citizen, permanent resident, or valid work permit).

We thank all applicants for their interest; however, only those selected for an interview will be contacted.

Accessibility Statement:

Bio Agri Mix LP is an equal opportunity employer. We are committed to an inclusive, accessible workplace. Accommodations are available upon request for candidates during all stages of the recruitment process. Please contact Human Resources to make arrangements.

Recruitment Process:

All applications are reviewed by our Human Resources team. We do not rely on automated decision-making tools to screen or select candidates. Hiring decisions are made by qualified personnel based on job-related criteria.

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