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Senior Specialist, Quality Assurance

Date: Oct 4, 2022

Location: Burnaby, British Columbia, CA

Company: Evonik Industries AG

Discover a world of opportunities. #HumanChemistry

See what chemistry can do for your career: careers.evonik.com


Exploring opportunities. Growing together.

 

VACANCY REFERENCE NUMBER 155766
 

Senior Specialist, Quality Assurance 

 

Location: Burnaby, BC

Legal Entity: Evonik Canada Inc.

Business Line: Health Care

 

What we offer

Evonik offers excellent benefits such as competitive compensation, benefit & pension plans, vacation and time off, and many wellness resources. 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! 

 

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.   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.

Click here to for a sneak peak of Evonik’s contribution to the COVID vaccine and how you could have a direct impact in helping our community 

https://www.youtube.com/watch?v=J8kqAoSzeNE

Click here to learn more about Evonik from our employees

 

RESPONSIBILITIES

 

RESPONSIBILITIES

Functional Expectations:

  • Develop, execute and maintain an effective & efficient program for shop floor quality for all GMP functions
  • Develop / maintain / revise training materials and tools to assure effective delivery of GMP training to the site; training topics include but are not limited to “Intro to GMP for New Employees”, “annual GMP Re-fresher training for existing employees”, “Contamination Controls for Aseptic Manufacturing”, “Good Documentation Practices”, “Data Integrity”, etc.
  • Act as QA lead to ensure non-conformance investigations are conducted in a thorough manner and documented in a coherent manner to capture the impact assessments, findings and identification of appropriate root cause(s) with applicable CAPAs
  • Provide QA support to client project document reviews including, but not limited to: validation protocols, master batch records, stability protocols, specifications, risk assessments, deviations, OOS reports, change controls, production, and laboratory records.
  • Execute line clearance and shop floor surveillance for production
  • Complete disposition of raw materials and finished products
  • Participate in internal and external audits
  • Act as QA representative for quality input and operational support on client and internal project

REQUIRED COMPETENCIES

  • In-depth and practical knowledge on cGMP requirements (e.g. Health Canada, FDA, ICH, and EU), especially in the area of shop-floor quality oversight and contamination controls
  • Experience working in a contract manufacturing organization / environment is preferred
  • Detail oriented to assure accuracy of data and information
  • Excellent technical writing and communication skills
  • Proven time management and organizational skills to work in a fast-pace environment and manage multiple projects concurrently
  • Strong interpersonal skills with the ability to influence others across multiple functions
  • Exhibits initiative to recognize and solve problems
  • Ability to work in an undefined environment
  • Must be flexible and willing to provide off hours support as needed
  • Ability to perform work utilizing a computer for extended periods of time
  • Proficient in computing (e.g. Microsoft Word, Excel, PowerPoint, Visio, etc.)
  • Proficient in data analysis (preferably have working knowledge of various risk analysis and statistical process control (SPC) tools)

 

 

 

REQUIREMENTS

 

  • REQUIRED EDUCATION & EXPERIENCE

  • Bachelor’s degree in Chemistry, Biological / Applied Sciences, Pharmaceutical Engineering, or equivalent experience
  • Minimum 5 years of experience in Aseptic / Sterile Manufacturing of Pharmaceutical / Biological products
  • Minimum 2 years of such experience in the Quality Unit
 

Your Application

To ensure the fastest process of your application and to protect the environment, please apply online via our careers portal at https://careers.evonik.com.

VACANCY REFERENCE NUMBER 155766

Evonik Corporation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status or any other legally protected status.

Please note that Evonik will not accept any unsolicited application documents sent by staffing firms. Evonik works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Evonik receive a candidate profile from a staffing firm with which it has no framework agreement, and should this candidate subsequently be considered in the recruitment process or offered employment, no claims from the staffing firm will be entertained in this regard.