Quality Assurance Specialist

Target Salary Range: $66,200 - $88,300 -

$Minimum – $Mid 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.

RESPONSIBILITIES

• Oversight of technical & compliance aspects of auditing at VAN
• Establish and maintain Quality System aspects of materials & supplier management programs
• Apply appropriate regulatory guidance by considering development stages as well as internal and client requirements
• Collaborate with partners at NC-HC to efficiently utilize site resources to audit and qualify suppliers
• Be a strong Quality partner/ collaborator to drive operational efficiencies to achieve sustainable quality compliance and meet the business objectives of the site
• Build strong relationships with the Quality team, internal and external (ie. personnel from other Evonik sites, suppliers) stakeholders to assure on-time delivery of products/ materials/ services that are quality compliant and fit for its intended purpose
• Develop and monitor metrics to evaluate effectiveness and compliance of internal and external audit programs
• Devise system for effective classification of materials / suppliers
• Ensure the day-to-day Quality Systems related activities are performed efficiently and effectively in accordance with procedures and policies.
• Responsible to meet fundamental cGMP requirements relating to their conduct and work practices to ensure SISPQ of products manufactured at Evonik Vancouver Laboratories.
• Develop, maintain and update applicable Quality related SOPs to assure the procedures are compliant with GMP, EHSS and company requirements.
• Assure all data and records are accurate, documented and maintained effectively and in compliance with Good Documentation Practice (GDP) and data integrity requirements
• Support/ review Deviation/ Non-conformance/ Change Controls and CAPAs to assure the actions and documentation are appropriate and completed in an accurate, adequate and timely manner.
• When required, actively participate in cross-functional team investigation and root cause analysis
• When required, lead as Change Controls and CAPA owner
• Participate in Quality Risk Management to support GMP operations
• Leads activities related to resolving major supplier and raw material issues
• Support / conduct / host internal and external audits
• Adhere to all EHSS programs, rules, and procedures of Evonik
• Perform other duties as required by Supervisor

REQUIREMENTS

• BSc. in chemistry, biological/ applied sciences, pharmaceutical engineering, or equivalent, with ≥ 5 years of work experience in GMP regulated environment
• Minimum 2 years of such experience within a Quality Unit
• Auditing experience certification (e.g., CQA) would be an asset
• Work experience in microbiology and/or sterile manufacturing would be an asset
• Sound knowledge of cGMP requirements (e.g., Health Canada, FDA, ICH, EU and ISO) and experience in the application and interpretation of cGMP requirements.
• Experience in change management or lean transformation an asset.
• Detail oriented to assure accuracy of data and information.
• Excellent technical writing, problem-solving, and communication skills.
• Proven time management and organizational skills to work in a fast pace regulated environment and manage multiple projects concurrently.
• Effective and professional interpersonal skills with abilities to influence others across multiple functions.
• Self-motivated with abilities to work in an undefined environment.
• Must be flexible and willing to provide off hours support, as needed to support GMP operations.
• Ability to perform work utilizing a computer for extended periods of time.
• Proficient in computing (e.g., Microsoft Word, Excel, PowerPoint, Visio, etc.).

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 https://careers.evonik.com.

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.