Job Overview:
Responsible for the daily monitoring, inspection, and enforcement of quality standards across all Empack’s operational sites. This role ensures that the full spectrum of products manufactured (including Industrial, Consumer, Cosmetics and GMP regulated products (OTC-DIN, NHP &FDA) consistently meets established safety, quality, and regulatory requirements. This is achieved through rigorous day-to-day process oversight and comprehensive review of all production records to guarantee compliance across the entire organization.
Job Responsibilities (Specific Tasks and Duties):
- Maintain, review and document GMP related forms and electronic records, documents, and files to ensure company processes comply.
- Maintain a consistent quality presence on the production floor. Monitor, review, and document GMP-related forms and electronic records to ensure company-wide compliance.
- Ensure that quality and regulatory standards and safety regulations are observed and work closely with production and IPQA teams for enforcement of these standards
- Prepare/ update, implement and maintain quality assurance policies and procedures through entire operational facilities
- Collaborate with other QA Specialists for completing annual refresher training, internal audits and other quality procedures.
- Review and reconcile all manufacturing batch package documentation, perform yield calculations and prepare production batch release forms.
- Lead and manage the facility wide Change management process.
- Identify, report, and investigate non-conformances. Coordinate with cross-functional teams, i.e. R&D Operations, Production, QC, R&D, Purchasing and RA to resolve deviations effectively.
- Review GMP forms and files to ensure strict Good Documentation Practices (GDP) are followed at all times.
- Assist the QA Manager in preparing for ISO, Health Canada, and Customer audits by compiling supporting documentation and assisting in drafting official responses to findings.
- Lead, assist or perform ISO/ GMP-mandated special event activities, including product recalls, out-of-limit investigations, and other emergency quality protocols. Compile supporting documents for all regulatory and Customer audits and corresponding response requirements
- Liaise with and support the Quality Systems & ISO Project Specialist in implementing and enforcing ISO regulations throughout the facilities. Proactively identify operational "roadblocks" and assist in developing solutions to overcome them.
- Provide ongoing support and assistance to the wider QA team.
- Perform other related duties/projects as assigned by the QA Manager.
The list of duties and responsibilities outlined above is representative and not a complete and detailed list of tasks which may be performed by an employee whose position has been matched to this job description.
Skills and Qualifications:
- Bachelor’s degree in science, Engineering, or Quality Management.
- 2+ years of experience in a Quality Assurance role within a GMP regulated manufacturing environment.
- Strong understanding of ISO, Health Canada (DIN/NHP) and FDA regulations is required.
- Ability to communicate firmly but professionally with production teams to enforce standards and overcome "roadblocks."
- High attention to detail with the ability to manage documentation for two separate buildings simultaneously.
- Strong proficiency in Microsoft Office and QMS software.
Pay: $55,000.00-$60,000.00 per year
Work Location: In person
