Quality Assurance Specialist

4 weeks ago

StrathroyCaradoc, Canada Catalent Pharma Solutions Full time

Position Overview

Catalent Pharma Solutions is a prominent, rapidly expanding public organization and a key collaborator in the pharmaceutical sector, dedicated to the advancement and production of innovative therapies for patients globally. Your skills, insights, and enthusiasm are vital to our mission: enhancing the quality of life for individuals. Catalent prioritizes a Patient First ethos, emphasizing excellence in quality and adherence to regulations, ensuring the safety of every patient, consumer, and employee.

This role is situated in a facility in Ontario, one of our two Canadian locations that provide softgel development and manufacturing services for the Pharmaceutical and Consumer Health sectors. We offer a comprehensive suite of integrated formulation, manufacturing, analytical, and packaging services, delivering full-service solutions.

Reporting to the Quality Assurance Supervisor, the Quality Assurance Associate fosters a culture of quality compliance and ongoing enhancement, aligning with governmental, customer, and business standards. The emphasis is on proactive measures to prevent quality concerns rather than merely identifying them. Additionally, the Quality Assurance Associate will conduct final product audits for release and provide guidance and training to operators and supervisors on proper documentation practices and cGMP requirements.

Key Responsibilities:

  • Conducts in-process documentation audits and product quality assessments during production, ensuring all concerns are communicated to production personnel, management, and QA leadership.
  • Performs final release audits of batch documentation to confirm that all products are manufactured in accordance with cGMPs and SOPs, fulfilling all necessary duties for product release.
  • Assists in investigating manufacturing discrepancies and deviations reported by production teams.
  • Executes in-process product quality checks and documentation evaluations.
  • Conducts weekly compliance audits and monitoring across all production and packaging departments, preparing reports for QA management.
  • Acts as the QA representative during shifts, making decisions and resolving issues, and escalating significant concerns to production and QA management as needed.
  • Performs line clearance verifications of equipment and processing areas during product changeovers, which may include testing and verification of vision equipment.
  • Undertakes additional responsibilities as assigned.

Candidate Qualifications:

  • 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.
  • Meticulous attention to detail.
  • Excellent prioritization and time management abilities.
  • Strong interpersonal and communication skills, both verbal and written.
  • Ability to work independently with minimal oversight.
  • Proficient in MS Excel and Word.
  • While performing job responsibilities, the employee must be able to communicate effectively.
  • Frequent use of hands and fingers is required, including handling and manipulating keyboard keys. Manual dexterity is essential.
  • Occasional standing, walking, reaching, bending, twisting, and stooping may be necessary.
  • Vision capabilities required for this position include close vision.
  • Potential exposure to chemicals may occur.

Why Choose Catalent:

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

Catalent offers fulfilling opportunities to advance your career. 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 organization where employees collaborate with pharmaceutical, biopharmaceutical, and consumer health companies of all sizes to progress new medications from initial development through clinical trials to market. Catalent produces over 70 billion doses annually, each one relied upon by individuals 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 many of our recruitment and onboarding processes to ensure everyone's safety. The Human Resources team will communicate all necessary safety protocols throughout each stage.

Personal initiative. Dynamic environment. Meaningful contributions.

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

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