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Change Control Specialist

Catalent Pharma Solutions

This is a Full-time position in Hamilton, ON posted November 15, 2022.

Position Summary: Catalent Pharma Solutions is hiring a Change Control Specialist for our site in Morrisville, NC.

This is a full-time role position: Monday – Friday, days.

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.

The Research Triangle Park (RTP) facility is Catalent’s Center of Excellence for Analytical Services and is also home to Catalent’s Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.

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 Responsible for the execution of assigned activities for technical support and process validation related to new products, process, equipment, and troubleshooting of current processed associated with Metered Dose Inhalers (Dispensing, Formulation, Filling, and Post Equilibration Testing), Sterile/Non-Sterile Liquids (Compounding, Filling, Lyophilization, and Inspection) and Dry Powder Inhalation Manufacturing (Blending, Capsule and Reservoir Filling of Devises) Subject Matter Expert for the Catalent Quality Systems (Change management, Deviation Management, CAPA).

Keep current Quality requirements status for timely turnaround and closure of investigations, change controls, CAPA to support on time delivery.

Approvals of Events, Deviations, CAPAs, change controls (lab and manufacturing) Responsible for review and approval of Calibration Procedures and forms and Maintenance forms (Instrument onboarding forms, Retirement forms etc.) Responsible for review and approval of Validation documents (periodic reviews, lab instrument qualification, computer system validation, User Requirement Spec., Trace Matrix, Risk Assessments etc.) Responsible for change control process administration at Morrisville site Other duties as assigned The Candidate Bachelor’s degree in engineering, life sciences, or pharmacy with five plus (2) years of relevant experience in a Quality function (supporting laboratory Systems, Validation, change management, investigations and CAPAs).

Direct experience with MDI and Sterile/Non-Sterile Processes or DPI manufacturing processes is ideal Qualified candidates must have worked in the pharmaceutical industry ideally at a CMO/CDMO Working knowledge of TrackWise and Documentum is required Demonstrated skill in principles of cGMPs, Laboratory testing processes, Root Cause Analysis Demonstrated knowledge of investigations, Change management and CAPA systems and regulatory/ industry standards Advanced knowledge in validation principles of Lab Instrument, Computer System and method validation/ verification/ transfer Physical Requirements: Individuals may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds.

Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Must have the ability to wear a respirator Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture 19 days of PTO 8 paid holidays Dynamic, fast-paced work environment Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Competitive salary Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement GymPass program to promote overall physical wellness Perkspot
– offers exclusive or private discounts from approximately 900 merchants in a wide array of categories 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.

As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety.

The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative.

dynamic pace.

meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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 .

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.

Important Security Notice to U.S.

Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media.

If you receive any such request, DO NOT respond— it is a fraudulent request.

Please forward such requests to for us to investigate with local authorities.