Quality Assurance Associate
Catalent Pharma Solutions
Strathroy, ON
Position Overview:
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Position Summary

The Quality Assurance Associate reports to the Quality Assurance Supervisor.

Strathroy, Ontario is one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full service turnkey solutions.

Start your career in pharmaceutical manufacturing and make an impact on our patients lives.

The Quality Assurance Associate is responsible for preparing the final product audit for product release, coaching and training our operators and supervisors on proper documentation practices and cGMP requirements. The Quality Assurance Associate role participates in special projects as required in other areas of Quality and Compliance.

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 Quality Assurance (QA) management;
Performs Final Release auditing of batch documentation ensure all product has been manufactured in compliance with cGMP's (Good Manufacturing Practices) and SOP's (Standard Operating Procedures). 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 which includes completing quality checks as required;
Performs compliance audits in all production departments and prepares result reports for product and QA management. Follows up on outstanding corrective actions from the audits to ensure timely completion of the action;
Acts as QA representative on shift in decision-making and issue resolution, escalating serious issues to production management and QA management as required.

The Candidate

Bachelor's Degree in Science (Chemistry or Biochemistry preferred) is required;
Minimum 2 years related experience, pharmaceutical and/or GMP an asset;
Advanced computer skills in Microsoft office suite with emphasis on Excel and Word;
Extremely detailed oriented, with the ability to excel in a fast-paced environment;
Excellent communication skills - verbal and written. Developed interpersonal skills with the ability to work in a team environment and with multiple departments;
Flexible to work a 12-hour rotating continental shift.

Position Benefits

Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance);
Group Retirement Savings – Registered Pension Plan (RPP) with employer contributions;
Paid Time Off Programs incl. vacation, banked time & personal time;
Employee Reward & Recognition programs;
Opportunities for professional and personal development & growth incl. tuition reimbursement.

We will identify candidates based on the following Catalent Competencies:

Leads with Integrity and Respect;
Delivers Results;
Demonstrates Business Acumen;
Fosters Collaboration and Teamwork;
Champions Change;
Engages and Inspires;
Coaches and Develops.
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 www.catalent.com/careers to explore career opportunities.

C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation or gender identity. 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.