Sr. Project Manager, Quality Assurance (QA)

Responsibilities

• Maintain and revise QA related procedures, as needed.
• Maintain cGMP training systems and perform on-site team member training in Quality related matters
• Ensure GxP support and oversight, as applicable, for relevant site functions and activities
• Support QA team members with Senior QA level knowledge, experience, guidance, coaching and mentoring, as required
• Perform QA batch record review and disposition of manufactured early phase clinical product batches.
• Provide final QA approval of investigations and disposition of any impacted product batches.
• Evaluate deviations and propose batch rejections, if applicable.
• Perform QA review and approval of the following, as needed:
• Environmental monitoring data in GMP cleanrooms and adjacent areas, as well as Clean Utility monitoring data
• Investigation of non-conforming product
• Investigation of out of specification (OOS) results
• Manage and approve Change Controls, as required for facilities, equipment, systems and processes, Corrective Action/Preventiv

Benefits

Additional Information

Target Salary Range: $101,500 - $135,300 per year (salary to be determined by education, experience, knowledge, skills and abilities of applicant, internal equity, and alignment with market data) EVONIK Vancouver Laboratories (VAN), the operating drug delivery service site of Evonik Canada Inc., is a Contract Development and Manufacturing Organization (CDMO) that provides CMC services to biotechnology and pharmaceutical companies engaged in the development and manufacture of complex delivery-based drug formulations. EVONIK has a successful track record of helping Customers move their programs forward. Evonik's Vancouver business operations is a development partner to the world's pharmaceutical companies for parenteral lipid nanoparticle drug products. As an enabling contract development manufacturing organization (CDMO) partner, we offer drug formulation design, process development, scale-up, and clinical production. EVONIK's range of services extends from initial formulation prototype identification, manufacturing process development & scale-up, analytical method development & validation to support raw material, in-process, release and stability testing, all the way through to sterile product manufacturing under GMP for Phase I-II clinical trials. Products include the LIPEX® line of Extruders, which are designed to enable small-scale to commercial scale manufacturing of liposomal drug products. With over 25 years of experience and having transacted business in about 50 different countries, WHY EVONIK? Evonik offers an excellent Total Rewards Program including: Competitive base compensation & bonus; employer paid health & dental benefits complimented with wellness education sessions; Financial planning resources & savings plans including RRSP & Defined Contribution pension plans; Generous vacation and paid time off to support Community Volunteer activities; Financial assistant for fitness memberships. And there is more...access to a Comprehensive Health Promotion program and Regional and Global resources for ongoing training and development. Best of all, you will work within a great team of professionals in an engaging workforce who value trust and openness. Are you looking to join a dynamic company with an exciting and expanding future in the pharmaceutical industry? Then Evonik is the next step in your career. Grow with us! Click here to learn more from our Vancouver Laboratories employees: https://www.youtube.com/watch?v=s5X15sKUEzs WHY VANCOUVER? Vancouver has something for everyone! British Columbia is beautiful and exciting. From the people, to the mountains, to the sprawling coastline, everywhere you look. Nestled on the warm Pacific Coast with the Rockies blocking cold arctic winds. Vancouver has the good fortune of being spared the typically chilly winters associated with Canada. Vancouver is often called 'two cities in one' because people are equally prone to enjoy the bustling nightlife and experiencing a plethora of activities in the surrounding nature. Imagine enjoying a day-long trek through our world-renowned rain forests, then heading into the city for a night out. Vancouver truly is as beautiful as people say and more.

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