Job Information
Catalent Pharma Solutions Quality Assurance Document Control in Philadelphia, Pennsylvania
Job Description
Quality Assurance Document Control
Position Summary:
Catalent Pharma Solutions is Philadelphia, PA is hiring for a Quality Assurance Document Control. The Quality Assurance Document Control individual is responsible in preparing customer files, review and approve batch records, and release batch records and finished product. The Quality Assurance Document Control individual acts as the primary liaison to our customer’s quality assurance groups for batch record review and release. The Quality Assurance Document Control manages the communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.
This is a full-time role position: Monday – Friday, 7:30am-4:00pm.
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
Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.
Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.
Primary liaison with client for batch release.
Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.
Ensure timely release of batch for protocol initiation date.
Release batch within scheduling database.
Communicates SQDC countermeasures and safety issues to Quality Management.
Ensures QADC metrics are met or acts to correct.
The Candidate
BA/BS Degree OR Minimum of a High School Diploma with relevant industry experience.
Prior GMP experience strongly preferred.
Experience with inspections or Batch Record Review a plus.
Good organizational/time management skills and ability to multi-task.
Challenges status quo and initiates improvements.
Good communication and math skills.
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 (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .