Quality Assurance Specialist

Evonik; Burnaby; On-site; CAD 66,000 - 89,000; Full time

Job summary

Join a leading global organization as a Quality Assurance Specialist, where your expertise will help ensure compliance and quality in a dynamic environment. This role involves maintaining quality systems, overseeing audits, and collaborating with internal and external stakeholders to ensure that products meet the highest standards. You'll have the opportunity to work with cutting-edge technology in the pharmaceutical industry, contributing to the development of innovative drug formulations. If you're detail-oriented, possess strong communication skills, and thrive in a fast-paced setting, this position offers a chance to make a significant impact in a company committed to excellence and sustainability.

Qualifications

• BSc. in relevant field with 5+ years in GMP regulated environment.
• Minimum 2 years in a Quality Unit, auditing experience preferred.

Responsibilities

• Oversee technical and compliance aspects of auditing.
• Develop and maintain Quality System aspects for materials management.

Skills

Attention to Detail

Technical Writing

Problem-Solving

Communication Skills

Interpersonal Skills

Time Management

Organizational Skills

Flexibility

Education

BSc. in Chemistry or Biological Sciences

Certification in Auditing (e.g., CQA)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Visio

Job description

Quality Assurance Specialist

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Locations: Burnaby, BC

Time Type: Full time

Posted on: Posted 30+ Days Ago

Job Requisition ID: R35786

Target Salary Range: $66,200 - $88,300 per year (salary to be determined by education, experience, knowledge, skills and abilities of applicant, internal equity, and alignment with market data)

About Evonik: Evonik Vancouver Laboratories (VAN) is a Contract Development and Manufacturing Organization (CDMO) providing 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. Our Vancouver business operations are a development partner to the world’s pharmaceutical companies for parenteral lipid nanoparticle drug products.

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 stakeholders to assure on-time delivery of products/materials/services that are quality compliant and fit for their intended purpose
• Develop and monitor metrics to evaluate effectiveness and compliance of internal and external audit programs
• Devise a 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 compliance 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 accurately and in a timely manner.
• Participate in cross-functional team investigation and root cause analysis when required
• Lead as Change Controls and CAPA owner when required
• Participate in Quality Risk Management to support GMP operations
• Lead 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 a 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 is 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-paced 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 processed as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as an 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: Evonik Canada Inc.

About Us

This is your opportunity to join a thriving global organization that combines cutting-edge science, technology and engineering with world-class business services to create solutions that answer real-world problems. If you join us, we’ll expect you to take ownership of your work, team up with other great minds, and add your name to creations that make a positive difference for generations. As one of the world leaders in specialty chemicals operating in more than 100 countries with over 32,000 employees, we need your diversity of thought to make us better. In return for your passion, initiative and creativity, you’ll enjoy opportunities to improve and to be respected for your contribution.