Quality Control Specialist

4 weeks ago

StrathroyCaradoc, Canada Catalent Full time

Quality Assurance Associate

Position Overview

Catalent is a prominent, rapidly expanding public organization and a key collaborator for the pharmaceutical sector in the creation and production of innovative therapies for patients globally. Your skills, insights, and enthusiasm are vital to our mission: to enhance the quality of life for individuals. Catalent prioritizes a Patient First ethos through superior quality and regulatory adherence, ensuring the safety of every patient, consumer, and employee.

This role is situated in a facility that specializes in softgel formulation and production for the Pharmaceutical and Consumer Health sectors. We provide a comprehensive array of integrated formulation, manufacturing, analytical, and packaging services to deliver complete turnkey 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 organizational standards. The emphasis is on preventing quality issues rather than merely identifying them. Furthermore, the Quality Assurance Associate will conduct final product audits for release and provide guidance and training to operators and supervisors on accurate documentation practices and cGMP regulations.

Key Responsibilities:

Conducts in-process documentation audits and product quality assessments during production, ensuring all concerns are relayed to production staff, management, and QA leadership. Executes Final Release audits of batch records to confirm all products are manufactured in accordance with cGMPs and SOPs, fulfilling all tasks necessary for product release. Aids in the examination of manufacturing challenges and deviations reported by production teams. Performs in-process product quality evaluations and documentation reviews. Conducts weekly compliance audits and monitoring across all production and packaging departments, preparing results reports for QA management. Acts as the QA representative during shifts, engaging in decision-making and issue resolution, escalating significant matters to production and QA management as needed. Carries out line clearance verifications of equipment and processing areas during product changeovers, which may involve testing and verifying vision 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, and/or GMP environment is advantageous. Strong analytical and problem-solving capabilities. Highly detail-oriented. Excellent prioritization and time management abilities. Strong interpersonal communication skills. Exceptional verbal and written communication skills. Ability to work independently with minimal oversight. Proficient in MS Excel and Word. The role requires verbal communication and active listening. Frequent use of hands and fingers for keyboard manipulation is necessary. Occasional standing, walking, reaching, bending, and other physical activities may be required. Close vision is necessary 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 with employer contributions. Employee Reward and Recognition programs. Opportunities for professional and personal development, including tuition reimbursement.

Catalent provides rewarding opportunities for career advancement. Catalent is a leader in drug development and delivery, helping to bring numerous life-saving and life-enhancing products to patients worldwide. We collaborate with pharmaceutical, biopharma, and consumer health companies of all sizes to advance new medicines from early development through clinical trials to market. Catalent produces billions of doses annually, each one vital to someone in need. Join us in making a significant impact.

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 teams 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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