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Associate, QAIP
Apotex Inc.Quality Assurance specialist ensuring GMP compliance in pharmaceutical manufacturing. Responsible for overseeing sterile manufacturing practices and continuous quality improvement on the production floor.
About the role
Key responsibilities & impact- Responsible to ensure quality products are manufactured and packaged according to Good Manufacturing Practices (GMP) and established Standard Operating Procedures (SOP)
- Provide continuous quality oversight on the production floor to support real-time, compliant decision-making
- Serve as QA Subject Matter Expert for aseptic practices during sterile manufacturing
- Perform routine inspections of production and packaging areas to ensure adherence to established standards and procedures
- Initiate, lead, and support deviation investigations, non-conformances, and CAPA implementation to ensure timely, compliant resolution
- Review and approve production and batch documentation, focusing on sterile manufacturing records and data integrity
- Coach and mentor production and quality personnel on aseptic practices and GMP expectations
Requirements
What you’ll need- Bachelor of Science degree or equivalent in a related discipline or College Diploma in a related discipline
- Strong working knowledge of GMP, cGMP, HPFBI and FDA requirements
- Strong working knowledge of compliant aseptic practices, contamination control, and environmental monitoring
- Excellent written and verbal communication skills in English
- Demonstrated experience in leading and motivating personnel by influencing without authority within a fast paced environment towards a common goal(s)
- Strong computer skills, good organizational, inter-personal and communication skills
- Flexibility to work in day and night 12 hours continental shifts in rotation (7 Days & 7 Nights Per month)
Benefits
Comp & perks- Accommodation for applicants with disabilities during the recruitment process
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Good Manufacturing Practices (GMP)Standard Operating Procedures (SOP)aseptic practicesdeviation investigationsnon-conformancesCAPA implementationproduction documentationbatch documentationdata integrityenvironmental monitoring
Soft Skills
written communicationverbal communicationleadershipmentoringorganizational skillsinterpersonal skillsinfluencing without authorityflexibilityteam motivationdecision-making
Certifications
Bachelor of Science degreeCollege Diploma