Quality Control Specialist

4 weeks ago

StrathroyCaradoc, Canada Catalent Full time

Quality Assurance Associate

Position Overview

Catalent stands as a prominent, rapidly expanding public entity, serving as a vital collaborator for the pharmaceutical sector in the innovation and production of groundbreaking therapies for patients globally. Your skills, insights, and enthusiasm are crucial to our vision: to enhance the quality of life for individuals through improved health outcomes. Catalent is dedicated to fostering a Patient First ethos through superior quality and regulatory adherence, ensuring the safety of every patient, consumer, and Catalent team member.

This role is situated in a facility that specializes in softgel formulation and production capabilities for 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 to the Quality Assurance Supervisor, the Quality Assurance Associate is instrumental in cultivating a culture of quality compliance and ongoing enhancement, aligning with governmental, customer, and organizational standards. The emphasis is placed on proactive measures to avert quality concerns rather than merely identifying them post-factum. Furthermore, the Quality Assurance Associate will conduct final product evaluations for release and provide guidance and training to operators and supervisors regarding accurate documentation practices and current Good Manufacturing Practices (cGMP).

Key Responsibilities:

Conducts in-process documentation audits and product quality assessments during production, ensuring all findings are communicated effectively to production personnel, management, and QA leadership. Executes Final Release audits of batch records to confirm that all products are manufactured in accordance with cGMP and Standard Operating Procedures (SOP). This includes fulfilling all responsibilities necessary for the final product release. Aids in the investigation of production issues and deviations reported by manufacturing teams. Performs ongoing product quality assessments and documentation reviews. Carries out weekly compliance audits across all production and packaging areas, compiling reports for QA management. Acts as the QA representative during shifts, engaging in decision-making and problem resolution, escalating significant issues to production and QA management as necessary. Conducts line clearance verifications of equipment and processing zones during product changeovers, which may involve testing and verification of visual inspection equipment. Undertakes additional responsibilities as assigned.

Ideal Candidate Profile:

A Bachelor's degree in a scientific discipline, Engineering (Chemistry, Biochemistry), or a related field is essential. Previous experience in a manufacturing, pharmaceutical, or GMP environment is advantageous. Strong analytical and problem-solving capabilities. Highly detail-oriented. Excellent prioritization and time management abilities. Strong interpersonal and communication skills, both verbal and written. Ability to work independently with minimal oversight. Proficient in advanced computer applications, particularly MS Excel and Word. While fulfilling job responsibilities, the employee must be able to communicate effectively and hear clearly. The role often requires sitting and using hands and fingers for keyboard manipulation, necessitating manual dexterity. Occasional standing, walking, reaching, bending, twisting, and other physical activities may be required. Close vision is necessary for this position. Potential exposure to chemicals is a consideration.

Why Choose 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 offers fulfilling career opportunities Become part of a global leader in drug development and delivery, contributing to the advancement of over 7,000 life-saving and life-enhancing products for patients worldwide. Catalent is an innovative and expanding international organization where employees collaborate with pharmaceutical, biopharmaceutical, and consumer health companies of all sizes to progress new medicines from initial development through clinical trials to market readiness. Catalent produces over 70 billion doses annually, each one vital to a patient relying on our commitment. Join us in making a significant impact.

Catalent prioritizes 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.

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

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