Quality Assurance Associate
Reporting to the Head of Quality Assurance, the Quality Assurance Associate participates in the completion of milestones associated with specific projects and supports ongoing SOP Management, Management of Deviations, CAPAs, Change Management, Annual Product Reviews and general quality management systems responsibilities in support of the manufacture, packaging and release of commercial cannabis products.
- Generates, maintains and mange Quality Assurance and eQMS standard operating procedures (SOPs).
- Acts as Subject Matter Expert (SME) for Quality Risk Management.
- Reviews deviation and investigation records, includes tracking, follow-up, and reporting/trending. Ensures GMP/GPP/GDP and deviation procedures are followed.
- Reviews Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
- Works with all departments to guide the timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations.
- Helps the Quality Hold and Release Manager with the review of batch records for product release.
- Oversees controlled document and system changes and performs detailed impact analysis to ensure all necessary GMP/GPP and qualification action items have been added to the change controls, as well as executed.
- Collaborate and liase with business to review and manage Change Control Requests. Ensures GDP and change management procedures are followed.
- Assists with monitoring all internal QMS compliance through performing internal audits, including production, facilities, validation and the laboratories.
- Incollaboration with Quality colleagues identifies areas for continuous improvement within the eQMS. Collaborates significantly with cross functional groups, including Quality Assurance, Manufacturing, Process Development, Facilities, and Regulatory Affairs on quality assurance matters.
- Completes APR reports in accordance to the schedule, gathering information available from batch records, investigations, product changes, complaints etc.
- Cross-train with other QA Associates/Specialists.
- Responsible for Logbook issuance, control, and review.
- Files and maintains controlled documents.
- Other duties as assigned
- Assertive and diplomatic, with excellent analytical, trouble shooting, and decision-making skills.
- Able to take directions and complete tasks with minimal supervision.
- Supporting and mentoring.
- Flexible working schedule, able to answer questions during off hours to support the team.
- Ability to quickly learn new and novel manufacturing processes supporting new clients in a fast-paced environment.
- Proven reliability and autonomy with reoccurring tasks.
- Motivated individual who can work independently or in a team setting to complete.
- Minimum of a B.Sc. in a science discipline or related diploma program.
- 3-5 years of experience in Quality Assurance of GMP / GPP/GDP -related experience in pharmaceutical or healthcare manufacturing facilities.
- Thorough knowledge of cGMP/GDP/GPP international regulatory compliance in addition to Regulatory/ Operations experience in a GMP/GPP environment.
- Strong knowledge of MS Word, Excel, Outlook and electronic databases.
- Bilingual: English and French
- Position based in Huntingdon, Quebec
- All successful candidates are required to pass background checks.
- Environment: Works in an office environment within a manufacturing environment with regular or some exposure to dust, noise, and odors.
- We cherish Québec’s culture and values.
- We believe cannabis can help Québecers and Canadians live better lives.
- We take pride in family, friends and living full, balanced lives.
- Safety and security is critical to the success our business.
- We currently work from two locations in Québec: A 55,000 square-foot cutting-edge facility in Huntingdon and new offices in Montréal’s Villeray neighbourhood.
- Our executives have world-leading experience in government regulated industries.
We look forward to hearing from you. Please reach out (with relevant information and background materials) and let us know why ROSE is a perfect fit for you before this.
**Only selected candidates will be contacted