Coordinator, Compliance
About The Position
Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake. When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector. We are seeking a detail-oriented Coordinator, Compliance to support pharmaceutical manufacturing operations at our Biotechnology Business Development Centre. This role is responsible for creating and managing GMP-compliant technical documentation, ensuring regulatory adherence, and supporting batch record review, audits, and quality processes. The successful candidate will be working cross-functionally with Production, Quality, and Engineering teams and will help maintain inspection readiness and uphold data integrity in a fast-paced, regulated environment, contributing to critical drug development and manufacturing initiatives. Please note this position requires full-time on-site presence.
Requirements
- Bachelor’s or Master’s degree related to pharmaceutical product manufacture.
- An equivalent combination of education and experience will be considered.
- 1-3 years of experience in cGMP regulated pharmaceutical manufacturing environment.
- Ability to take direction.
- Enthusiastic and willing to learn.
- Strong oral and written communication.
- Good interpersonal skills with the ability to interact with people at all levels with sensitivity and tact
Nice To Haves
- Experience in pharmaceutical manufacturing is preferred.
- Strong technical writing skills, independently create SOPs, investigate and write deviations, initiate change controls is preferred.
Responsibilities
- Author, revise, and manage SOPs, Batch Manufacturing Records, Work Instructions, and Master Production Records.
- Ensure clarity, accuracy, and compliance with GMP requirements.
- Maintain documents within QMS systems.
- Ensure adherence to GMP regulations (FDA, Health Canada, EU GMP).
- Ensure ALCOA+ data integrity principles are followed.
- Perform periodic document reviews.
- Review executed batch records for completeness, accuracy, and compliance.
- Identify discrepancies and collaborate with QA and production teams.
- Support change control processes and documentation updates.
- Assist deviation investigations and CAPA implementation.
- Support internal and regulatory audits.
- Maintain documentation in an inspection-ready state.
- Coordinate SOP training assignments.
- Collaborate cross-functionally with Production, QA, QC, Validation, and Engineering teams.
Benefits
- Comprehensive health coverage plan with 100% premium coverage for employees and dependents.
- RRSP Matching Program with API matching contributions up to 1-3% of base salary.
- Access to professional development opportunities including training programs, workshops, conferences, and certifications.
- Generous paid time off (PTO) policy including vacation days, medical/personal days, and holidays.
- Green Transit Allowance for employees who use environmentally friendly transportation for at least 75% of their commute.
- 20 Work From Home days for eligible employees, subject to job function, company needs, and manager approval.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
