QC Specialist

Target Salary Range:

$77,900 - $103,800 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.

What we offer

Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us.

Click on the link below to learn what our employees have to say about Evonik:

RESPONSIBILITIES

Leadership/ Functional:

• Proactively collaborate with stakeholders of various functional groups to prioritize the work for QC to meet the business needs to achieve the best-in-class operation for a Contract Development and Manufacturing Organization (CDMO)
• Be able to effectively influence QC team members to optimize the planning, daily and weekly QC schedules, and operational activities
• Identify gaps and define implementation strategies to achieve operational efficiencies and improvements

Operational Excellence & Planning:

• Act as a QC representative to provide operational input for clients' projects
• Attend routine operational and project meetings; provide QC progress updates to Project Management and the site operational team
• Bring strategic/ tactical plans into attainable QC actions to achieve on-time delivery of tasks and projects
• Communicate status of QC activities to external stakeholders and project-related updated to QC Manager
• -Prepare/revise and manage the QC master schedule / plans (including QC resource allocation and planning) to ensure proper alignment with business plan and delivery schedules
• Support the leading of the QC team to ensure all sample management and testing activities are performed efficiently and effectively, in accordance with approved SOPs, GxP requirements and expectations and EHSS requirements. Sample management includes cross-functional collaboration for RM sampling, arrangement of external testing, Utilities and Environmental Monitoring as well as proactive communication with those external labs regarding testing requirements and timelines for batch disposition.
• Draft drug product specification & sampling plans
• Ensure all stability projects are captured and maintained accurately in the QC system, which includes but is not limited to the following:
• Prepare stability protocols accurately in accordance with the project requirements for internal and external review and approval in a timely manner
• Ensure all stability samples are pulled and scheduled for testing within the defined timeframe
• Support periodic inventory count of all stability samples performed by the assigned QC analyst(s)
• Perform peer review and approval of QC data related to testing of raw material, in-process, release and stability materials
• Support the team to assure all reference standards are received and managed accurately in accordance with site procedure, includes but is not limited to:
• Coordinate with Project Management to receive the reference standards from Clients
• Coordinate the purchasing of the required reference standards
• Accurately maintain the master list of reference standards; proactively manage the expiry/ re-test dating to assure adequate supply of standards are available for testing as per defined schedule
• Participate in project(s) and temporary assignment(s) as assigned

REQUIREMENTS

• BSc. Or MSc. in Chemistry, Biochemistry, Microbiology, applied sciences or equivalent
• Approximately 5 to 8 years of experience in the parenteral pharmaceutical or biopharmaceutical industry
• Experience working in Quality Control is strongly preferred, with experience in project management, resource planning, and a CDMO environment as assets
• Proficient in real-life application of various program management/ resource planning tools (e.g., LEAN processes, Six Sigma, etc.) to drive operational excellence/ efficiencies
• Proven time management and organizational skills to work in a fast-paced, regulated environment and manage multiple projects concurrently.
• Demonstrated ability to think critically within applicable regulations for regulatory compliance and operational excellence
• Excellent technical writing, problem-solving, and communication skills.
• Detail oriented to assure accuracy of data and information.
• Effective and professional interpersonal skills with abilities to collaborate with others across multiple functions.
• Self-motivated with abilities to work in an undefined environment.
• Flexibility in work hours may be required
• Proficient in computing (e.g., Microsoft Word, Excel, PowerPoint, Visio, etc.) and performing appropriate data analysis and risk assessment

Your Application

To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at www.evonik.com/en/careers.html.

Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.

Your Talent Acquisition Manager:

Robin Rose

Company is

Evonik Canada Inc.