Quality Systems Specialist

Quality Systems Specialist

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.

Catalent Pharma Solutions is Morrisville, NC is hiring a Quality Systems Specialist who is responsible for management of ComplianceWire and EDMS system processes and provides oversight for electronic systems supporting GMP operations. The role requires the ability to interact and lead cross-functional teams as well as analyze data for trending and presentation.

This is a full-time salaried position. This is an onsite role. The core hours are Monday – Friday 9:00AM – 5:00PM.

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:

• Coordinate, revise and process/write Standard Operating Procedures, Instrument Calibration Procedures, Installation Qualification Procedures, and Guidelines to ensure documents are properly formatted and are consistent;
• Assist EDMS Authors with writing and revising procedures; provide guidance to ensure all appropriate documents are revised simultaneously;
• Act as the EDMS site expert and is a liaison between site users and the corporate Documentum team. Perform all necessary site-based testing in Documentum for changes;
• Lead major projects related to transitioning current processes and systems to electronic controlled documents in EDMS;
• Manage SOP Manual & Periodic Review process to ensure SOPs are reviewed according to requirements.
• As assigned, participate in various projects designed to build appropriate databases to improve processes and data structures ;
• Prepare reports to support Tier processes, monthly reporting and Quality Management Review; identify trends, provide assessments and prepare actions plans to drive improvements, as appropriate;
• Oversee all ComplianceWire and EDMS processes and procedures, identify gaps and recommend opportunities for improved efficiencies;
• Leading project aimed at improving efficiencies, quality and service across the organization
• Author reports and prepare professional presentations to present information to large, often cross-functional groups;
• Partner with Quality Assurance leadership to determine appropriate training requirements for new and revised Standard Operating Procedures;
• Identify, recommend and implement modifications for existing controlled document management processes;
• All other duties as assigned

The Candidate:

• Bachelor’s degree with at least three (3) years of experience in a pharmaceutical quality environment;
• General knowledge of laboratory operations, including chemistry and microbiology, preferred;
• Must have a solid understanding of quality systems and administrative practices and be able to function independently without close supervision;
• Must have knowledge of GMP Regulations and controlled document management system;
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 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
• 152 Hours 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives
• Generous 401K match
• Company match on donations to organizations
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement – Let us help you finish your degree or start a new degree!
• WellHub 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.

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 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.

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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.