QA Specialist
Evonik Canada Inc.
Burnaby, BC
What we offer

Evonik stands for attractive business and innovative prowess. Our corporate culture is geared toward results, profitable growth, and increasing the value of the company. Operating in over 100 countries, we benefit from close customer relationships and leading market positions. Over 36,000 employees are united by the understanding that no product is so perfect that you can't make it better. You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

Evonik Industries, its Burnaby, B.C. site, specializes in parenteral formulation development and manufacturing process design and implementation at small, intermediate, and large/commercial scales. This enables manufacturing of complex lipid-based formulations of therapeutic agents for preclinical and clinical testing in its state-of-the-art R&D and manufacturing facilities and transfer of drug product manufacturing to commercial facilities. Core manufacturing technologies include liposome extrusion, micro-mixing, tangential flow filtration (TFF) and sterile filtration with availability of small to large-scale equipment.

Click here to learn more about Evonik from our employees

RESPONSIBILITIES

Perform line clearance prior to and during manufacturing campaigns.
Review of documentation and final disposition of raw materials and finished products.
Review data to support the environmental monitoring of cleanrooms.
Review utility monitoring data
Review analytical data packages for batch release and stability studies.
Review and disposition of all manufacturing and packaging batch records.
Review and approve documents within the change control system
CAPA System

Support CAPA investigations
Facilitate interdisciplinary teams for root cause analysis of quality deficits using knowledge of problem-solving tools such as (Fishbone, 8D, 5 Whys, DMAIC, Brainstorming, etc…)
Identification of potential failure modes and risks
Resolving of customer issues appropriately
Continuous Improvement

Lead product quality and System improvements activities
Gather and analyze data to identify opportunities for quality improvement
Risk Management

Facilitate risk assessment activities such as design and process FMEA
Ensure product risks are identified and risk mitigation controls are put in place to eliminate product risk to an acceptable level

REQUIREMENTS

Bachelor of Science degree in Chemistry, Biology, or Engineering
Minimum five years experience in pharmaceutical or medical device manufacturing
Proficient computer skills, Microsoft Word, Excel, Access
High attention to detail, organization, and accuracy
Strong written and verbal communication skills
Good interpersonal skills
Knowledge of FDA’s cGMP and / or QSR quality system requirements
Comprehensive technical skills / knowledge
Applied statistics experience
Validation experience, including process validation
Advanced analytical and problem-solving skills
Experience in Regulatory Agency inspections
Experience in aseptic techniques and manufacturing

Preferred Qualifications:
Certified Quality Auditor, Certified Quality Engineer

Your Application

This is a great opportunity to work with engaged, committed and dedicated colleagues in an innovative and progressive environment. We offer a competitive salary, great benefits and career development opportunities. 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. Thank you for your interest in EVONIK we look forward to you joining our team!

VACANCY REFERENCE NUMBER 120329

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.