Quality Assurance Associate

Quality Assurance Associate

Position Summary

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. This is an exciting opportunity to play a pivotal role in developing the strategy for our new pharmaceutical site and shape the future of our operations in North America.

The Quality Assurance Associate creates a culture of quality compliance and continuous improvement, which meets the government, customer and business requirements. The Quality Assurance Associate is responsible for the final product audit for product release, coaching and training operators and supervisors on proper documentation practices and cGMP requirements.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role

• Performs in-process document auditing and product quality checks in production and ensures all issues are communicated to production employees, production management and QA management.

• Performs Final Release auditing of batch documentation ensure all product has been manufactured in compliance with cGMP’s and SOP’s. This includes performing all duties required to release the final product.

• Assists in the investigation of manufacturing issues and manufacturing deviations as reported by the production departments.

• Performs a check of completed in-process product quality checks and documentation review to allow progress of product to the next stage of manufacture “Stage Approval”.

• Performs weekly compliance audits/monitoring in all production and packaging departments and prepares result reports for QA management.

• Perform QA sign off after set-up to confirm that the manufacturing line has been set up as per requirements in batch documentation and associated SOPs.

• Acts as QA representative on shift in decision-making and issue resolution, escalating serious issues to production management and QA management as required.

• Performs line clearance verifications of equipment and processing areas during changeovers from one type of product to another type of product – may include testing/verification of vision equipment.

• Other duties as assigned.

The Candidate

• Bachelor’s Degree in Science, Engineering (Chem., BioChem.) or related field

• No previous experience required.

• Prior experience in a manufacturing, pharmaceutical and/or GMP facility would be an asset.

• Strong analytical and problem-solving skills

• While performing the responsibilities of the job, the employee is required to walk, talk and hear.

• The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. Use of manual dexterity is required.

• The employee is  required to stand, walk, reach with arms and hands, bend or twist, and to stoop, kneel, crouch or crawl.

• Walking/entering between GMP and office area interchangeably throughout the working hours.

• Vision abilities required by this job include close vision. 

Why You Should Join Catalent

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)

• Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions

• Paid Time Off Programs including vacation, banked time & personal time.

• Employee Reward & Recognition programs

• Opportunities for professional and personal development & growth including tuition reimbursement.

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.