Quality Specialist

Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Specialist. The Quality Specialist is responsible for system administration/support of the following Quality Systems (Track Wise, Documentum and Compliance Wire). The Quality Specialist supports activities associated with these systems in accordance with Catalent Site and Corporate policies and procedures. The Quality Specialist is also responsible for managing GxP record archiving activities and document retention / destruction. This individual must be flexible, have well developed computer skills, and can interact with all levels of management. Candidate must be a self-starter, organized, results-oriented individual with ability to articulate, receive, disseminate, and analyze data.
This is a full-time role position: Monday - Friday, 8:00am-4:30pm.
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.
This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
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 supporting Document Management activities including preparation, upload, approval and effectivity of controlled documents
• Responsible for the management of Logbooks, including retrieval and reconciliation ensuring department reviews are complete. Responsible for ensuring logbooks are replaced by retire date and archived per procedure
• Responsible for completing assigned site administrator training for ComplianceWire, TrackWise, EDMS, (and other quality systems as assigned)
• Responsible for archiving GxP documents off-site including document handling, documentation and data entry; storage and retrieval management
• Monitor and track training for compliance with GMP's and Site/CSS procedures; Supports the training program for cGMP training, procedural based training, and other training needs for performing tasks
• Supports completion of Annual Product Quality Review documents on schedule, as required
• Assist with internal and customer audits of the facility, as required. Provide documentation for Audit requests
• Assist in preparing the site for inspection by regulatory authorities and participate in regulatory inspections, as required
• Develop new procedures, and review and update existing procedures; Represent Quality Department on project teams and other internal Teams
• Perform other related duties as assigned to meet departmental and Company objectives

The Candidate

• High School/GED required; Associate degree preferred
• Computer skills preferred, familiarity of other software (Documentum, TrackWise and ComplianceWire) preferred; Computer proficiency in Microsoft Office products (proficient in Excel)
• Excellent written and verbal communications skills preferred
• Organized, detail oriented and able to multi-task preferred
• Ability to work cross-functionally with departments (Operations, Quality Assurance, Supply Chain, Project Management, and Engineering) and individuals at all levels within Catalent

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
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• 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 with possible bonus potential
• 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 - Let us help you finish your degree or earn a new one!
• 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 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.