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Quality Control Specialist

3 months ago

StrathroyCaradoc, Canada Catalent Full time

Quality Assurance Associate

Position Overview

Catalent is a prominent global organization, recognized for its rapid growth and as a key collaborator in the pharmaceutical sector, focusing on the development and production of innovative therapies for patients globally. Your skills, creativity, and dedication are vital to our mission: enhancing the quality of life for individuals through better health outcomes. Catalent prioritizes a culture centered on patient safety, quality excellence, and compliance.

This role is situated in a key facility in Canada, specializing in softgel formulation and manufacturing for both the Pharmaceutical and Consumer Health sectors. We provide a comprehensive suite of integrated services, including formulation, manufacturing, analytical testing, and packaging, delivering complete turnkey solutions.

Reporting directly to the Quality Assurance Supervisor, the Quality Assurance Associate fosters a culture of quality compliance and ongoing enhancement, aligning with regulatory, customer, and business standards. The emphasis is on proactive measures to prevent quality discrepancies. Additionally, the Quality Assurance Associate will conduct final product audits for release and provide guidance and training to operators and supervisors on proper documentation and cGMP standards.

Work Schedule:

12-hour Continental Shifts (Days and Nights)

Key Responsibilities:

  • Conducts in-process documentation audits and product quality assessments during production, ensuring timely communication of any issues to production staff and management.
  • Executes Final Release audits of batch records to confirm compliance with cGMP and SOP standards, fulfilling all necessary duties for product release.
  • Aids in the investigation of manufacturing discrepancies and deviations reported by production teams.
  • Performs ongoing product quality checks and documentation evaluations.
  • Carries out weekly compliance audits across all production and packaging departments, compiling reports for QA management.
  • Acts as the QA representative during shifts, making decisions and resolving issues, and escalating critical matters to production and QA management as needed.
  • Verifies line clearance of equipment and processing areas during product changeovers, which may involve testing/verification of vision systems.
  • Undertakes additional responsibilities as assigned.

Candidate Profile:

  • A Bachelor's degree in a scientific discipline, Engineering (Chemistry, Biochemistry), or a related field is required.
  • Previous experience in a manufacturing, pharmaceutical, or GMP environment is advantageous.
  • Strong analytical and problem-solving capabilities.
  • Exceptional attention to detail.
  • Proficient in prioritization and time management.
  • Strong interpersonal and communication skills, both verbal and written.
  • Ability to work independently with minimal oversight.
  • Advanced proficiency in MS Excel and Word.
  • The role requires verbal communication and auditory skills.
  • Frequent use of hands and fingers for typing and handling tasks is necessary.
  • Occasional standing, walking, reaching, bending, and other physical activities may be required.
  • Close vision is essential for this position.
  • Potential exposure to chemicals may occur.

Benefits of Joining Catalent:

  • Comprehensive benefits package including Health, Dental, Vision, and Life Insurance.
  • Group Retirement Savings plan with employer contributions.
  • Employee recognition and reward programs.
  • Opportunities for professional and personal development, including tuition reimbursement.

Catalent provides exceptional opportunities for career advancement. Join a global leader in drug development and delivery, contributing to the provision of over 7,000 life-saving and life-enhancing products to patients worldwide. Catalent is a dynamic and expanding international company where employees collaborate with pharmaceutical, biopharmaceutical, and consumer health organizations of all sizes to advance new medicines from initial development through clinical trials to market. Catalent produces over 70 billion doses annually, each one essential to someone in need. Be part of our mission to make a difference.

Catalent is dedicated to the health and safety of its employees, visitors, and the customers and patients we serve. In response to the global pandemic, we have adapted our recruitment and onboarding processes to ensure everyone's safety. The Human Resources team will communicate all necessary safety protocols throughout each stage of the process.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request through the appropriate channels. This option is reserved for individuals needing accommodation due to a disability.