Coordinator, Compliance

API (Applied Pharmaceutical Innovation); Edmonton; On-site; CAD 60,000 - 80,000; Full time

Benefits offered by this job

Comprehensive Health Coverage

Retirement Savings (RRSP matching)

Professional Development Opportunities

Generous Paid Time Off

Green Transit Allowance

Work From Home (20 days)

Job summary

API (Applied Pharmaceutical Innovation) in Edmonton is seeking a detail-oriented Coordinator, Compliance to support pharmaceutical manufacturing operations. This role focuses on creating and managing GMP-compliant technical documentation, ensuring regulatory adherence, and supporting audits and quality processes.

Applicants should possess a Bachelor’s or Master’s degree related to pharmaceutical manufacturing and 1–3 years experience in a cGMP environment. The position requires full-time on-site presence and offers numerous perks including health coverage and professional development opportunities.

Qualifications

• 1–3 years of experience in cGMP regulated pharmaceutical manufacturing environment.
• Experience in pharmaceutical manufacturing preferred.
• Strong technical writing skills; independently create SOPs and write deviations.

Responsibilities

• Author, revise, and manage SOPs and batch records.
• Ensure compliance with GMP regulations.
• Support internal and regulatory audits.

Skills

Technical writing skills

Knowledge of GMP regulations

Interpersonal skills

Ability to follow directions

Education

Bachelor’s or Master’s degree related to pharmaceutical product manufacture

Job description

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 work cross‑functionally with Production, Quality, and Engineering teams and 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.

Key Responsibilities

Technical Documentation Management

• 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.

Compliance Coordination

• Ensure adherence to GMP regulations (FDA, Health Canada, EU GMP).
• Ensure ALCOA+ data integrity principles are followed.
• Perform periodic document reviews.

Batch Record Review

• Review executed batch records for completeness, accuracy, and compliance.
• Identify discrepancies and collaborate with QA and production teams.

Change Control & Deviation Support

• Support change control processes and documentation updates.
• Assist deviation investigations and CAPA implementation.

Audit & Inspection Readiness

• Support internal and regulatory audits.
• Maintain documentation in an inspection‑ready state.

Training & Collaboration

• Coordinate SOP training assignments.
• Collaborate cross‑functionally with Production, QA, QC, Validation, and Engineering teams.

Qualifications

Education

• Bachelor’s or Master’s degree related to pharmaceutical product manufacture.
• An equivalent combination of education and experience will be considered.

Experience

• 1–3 years of experience in cGMP regulated pharmaceutical manufacturing environment.
• Experience in pharmaceutical manufacturing is preferred.
• Strong technical writing skills; independently create SOPs, investigate and write deviations, initiate change controls is preferred.

Personal Competencies

• 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.

Working Conditions

• Required travel between Edmonton API sites.
• This position requires on‑site presence.
• Work is performed in office and cleanroom environments.
• Gowning required for sterile operations.
• May require flexibility to support audits and production schedules.
• Lifting/pushing/pulling up to 25 lbs, and direct contact with alcohol/chlorine based disinfectant agents.
• Possible exposure to chemicals, machinery, or equipment.

Additional Required Documents

• Applications submitted without a resume AND cover letter will not be reviewed.

Perks and Benefits

Comprehensive Health Coverage: premiums are 100% covered, ensuring that you and your dependents receive necessary healthcare support.

Retirement Savings: API offers an RRSP matching program with matches up to 1–3% of base salary.

Professional Development Opportunities: Access to training programs, workshops, conferences, and certifications.

Collaborative and Inclusive Environment: Fosters teamwork, open communication, and a supportive atmosphere.

Generous Paid Time Off: PTO includes vacation days, medical/personal days, and holidays.

Green Transit Allowance: Eligible employees may enroll in the green transit program.

Work From Home: Eligible employees entitled to 20 Wfh days, subject to job function and manager approval.

Equality, Diversity and Inclusion Statement

Our team, clients, and stakeholders come from a variety of backgrounds. In recruiting, we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences, education, culture, gender, race, sexual orientation, religious or ethnic background, neurodiversity, and cognitive and physical ability.

Before employment, successful candidates will be required to meet the requirements of a pre‑employment screening, which includes background reference checks, educational credential verification, and criminal reference checks.

This position will remain open until filled.

For questions or accommodations, contact [e-mail].