Search Jobs
QA Consultant (Drug Substance)
3650 Gilmore Way Burnaby, BC 02210 CA
Job Description
- Start Date: ASAP
- Contract Length: 6–12 months
- Hours: Part-time, 20+ hours/week (could increase based on candidate skills and ability to support other programs)
- Location: Remote (U.S.); PST time zone preferred (manager is based in Vancouver)
Qualifications:
- Bachelor’s degree in a relevant field with 5–8 years of QA experience focused on drug substance for early phase programs (ideally at the manager level)
- Prior experience supporting API development, chemical synthesis, manufacturing, labeling, packaging, and distribution
- Strong background in reviewing DS and API documentation: master/executed batch records, deviations, change controls, CAPAs, and analytical data
- Ability to conduct or participate in audits, develop CAPAs, identify root causes, and mitigate risks
- In-depth knowledge of global GMP regulations, principles, industry standards, and best practices
- Support QA systems and activities, including:
- Change control
- Deviation and nonconformance management
- Complaint and recall handling
- Vendor qualification and audits
- Quality risk management
- GxP training programs and data quality audits
- Inspection readiness
- Assist with CDMO lifecycle activities: qualification, selection, tech transfer, and decommissioning
- Collaborate with CDMOs and internal teams to resolve quality issues; ensure product meets all applicable quality standards
- Support product release across various jurisdictions (e.g., US, EU, UK)
- Contribute to CAPA and quality risk systems to ensure timely compliance risk identification
- Apply risk-based review of GMP documentation, identifying key elements like CQAs, CPPs, and CMAs appropriate for the development phase
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
Share This Job:
Related Jobs:
About Burnaby, BC
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.