Production Compliance Associate

Production Compliance Associate 

Position Summary

• Work Schedule:  Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch.

• This position is 100% on-site at the Windsor site.

This position is located in Windsor, Ontario, 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.

Reporting to the Production Manager, the Production Compliance Associate is responsible for implementing, applying, and maintaining quality standards inside a manufacturing and packaging production environment. The Production Compliance Associate is also responsible for leading and supporting quality initiatives within the production department including processes, products, and personnel.

The Role:

• Leading and coordinating investigations within production including CAPA implementation

• Conducting operations compliance walkthroughs in production ensuring compliance to standard

• Working with training personnel in delivery of effective and prompt training

• Supporting the process of creating, reviewing, and revising master production documents ensuring consistency.

• Follows all SOP's, GMP's and Safety procedures

• Reports and implements corrective actions for trends and quality issues

• Trends and monitors operation-level compliance and communications to operations teams to ensure actions are taken to meet Quality UPIs

• Perform other duties as assigned.

The Candidate:

• Diploma or Bachelor’s degree  in sciences is required, Certificate or other formal qualification awarded based on completion of a course in a Life Sciences related field would be considered.

• 2+ years of relevant and practical experience in a manufacturing, pharmaceutical and/or GMP facility is preferred.

• Excellent interpersonal, organizational, and communication skills (both verbal and written).

• Works cooperatively in teams, communicated clearly, and has effective listening skills.

• Ability to work independently, as required, and complete daily activities according to schedule

• Strong problem solving and analytical skills

• Demonstrates trustworthiness by being honest, dependable, and reliable

• Strong working knowledge of computers and skilled in the use of Microsoft Office

• This position does not qualify for sponsorship.

• Candidates with non-Canadian credentials must provide an evaluation confirming the Canadian equivalency of the credentials as determined by the Alliance of Credential Evaluation Services of Canada (ACESC) such as WES.

• While performing the responsibilities of the job, the employee is required to 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 occasionally required to stand, walk, reach with arms and hands, bend or twist, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision.

Pay:

The final salary offered to a successful candidate may vary within this range $56,000 - $69,000, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a global employer, and this salary range does not reflect positions that work in other countries.

Why You Should Join Catalent:

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

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

• 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 [email protected]. 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.