Catalent Pharma Solutions is Philadelphia, PA is hiring for a Senior Quality Assurance Document Control.  The position requires the individual to coordinate the team and activities associated with batch record documentation, reviewing and approving batch records, and releasing batch records and finished product for both Commercial and Clinical product.  The position requires the individual to prepare customer files, review and approve batch records, and release batch records and finished product.  The position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.  Provides schedules to the Operations and Project Management teams regarding batch record reviews and customer responses. Also responsible for participating in special projects and/or tasks, and ensuring that all functions are being performed in compliance with SOPs.

This is a full-time role position: Monday – Friday, 1st shift.

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 ensuring batch record documentation aligns with activities performed and is compliant against Catalent procedures
• Responsibility for releasing supplies for Commercial or Clinical distribution
• Manage workload against the schedule for production priorities, working closely with the Scheduling and Production, Publish daily batch record status report
• Act as the Quality partner to support packaging operations and ensure projects are on-track.
• Sets priorities for the team to ensure task completion; coordinates work activities with QADC
• Investigate Events / Deviations regarding batch record documentation and support investigations led by Operations
• Interact with customers regarding questions, issues, metrics, batch records, etc.; respond to and investigate customer complaints
• Track and report metrics
• Confirm proper randomization schedule utilization for correct patient treatment group assignment

The Candidate

• Requires a BA/BS Degree OR Minimum of a High School Diploma with 3+ years relevant industry experience
• Requires cGMP experience
• At least 2 years of experience working a pharmaceutical or medical device environment is strongly preferred; 2 years of experience in Quality Assurance Document Control is strongly preferred
• Experience working with packaging batch records review and approval, release of products, packaging, labeling, assembly and distribution of clinical trial materials is preferred
• At least 2 years of experience with JD Edwards is preferred
• Advanced computer skills – including a high level of proficiency in Microsoft Office including Excel, Work, Outlook, IE, SAP/JDE

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.

Phila BST