Catalent Pharma Solutions in Philadelphia, PA is hiring a Label Associate. Label Control is responsible for the creation, preparation, control and destruction of primary and secondary packaging labels utilized in the packaging and distribution of stability, analytical, commercial, and clinical trial material. In addition, Label Control is responsible for the generation, issuance and control of Randomization Codes.

This is a full-time hourly position: Monday - Friday, 3:30pm - 12:00am (2nd 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

• This position is responsible for the storing, receipt, preparation, inspection, staging, return, storage and destruction of labels.
• Generate item masters
• Receive English, foreign text, booklet, multi-panel (e.g. 2 part-2 panel, 2 part-3 panel), Case Report Form [CRF], open-label and randomized labels into the inventory system
• Adhere to labeling project timelines to ensure required materials are ready within the agreed upon timeframe
• Responsible for creating all label inspection packets prior to the arrival/printing of all labels (English, foreign text, booklet, multi-panel, CRF, open-label and randomized)
• Responsible for formatting all randomization codes prior to printing/receipt of all clinical labels
• Interact with Quality Assurance, ensuring label inspections completed within timeline requirements
• Assist with staging labels for use in production
• Assist in rectifying label problems and reporting outcomes to Project Management
• Assist in destruction requests within a reasonable timeframe from receipt of request
• Process returned clinical labels utilized in production
• Assist in managing label stock utilized in internal printing via Inventory Adjustments through JD Edwards by performing inventory reports/resolution of all blank stock
• Participate in, and meet any assigned deliverables for, department projects/initiatives
• Recommend new, submit revisions to, and review Standard Operating Procedures (SOPs)
• Ensure compliance to GMPs, SOPs, and FDA rules and regulations
• Other duties as assigned

The Candidate

• High school diploma/equivalency required
• Bachelor’s Degree preferred
• 0-2 years work experience.
• Clinical supplies label experience preferred.
• Computer literate with experience using spreadsheets and word processing programs.
• Knowledge and experience with cGMP and FDA regulations preferred.
• Possess above average verbal, written and interpersonal communication skills
• Fluent in managing Microsoft Outlook
• Possess above average math skills
• Computer aptitude in Word processing, Microsoft access, and Excel
• Fluent in working with Excel spreadsheets for formatting Randomizations for use in Production
• Detail oriented and possess ability to handle multiple projects and tasks
• Ability to proofread / inspect all labels i.e. blank label stock and printed clinical labels
• Need the ability to read small/repetitive text patterns and numeric sequences
• Organized, self-motivated, and goal-oriented
• Customer service oriented with a team-player attitude
• Ability to work independently.
• General knowledge of cGMPs and understanding of the pharmaceutical industry, preferably in Clinical Supplies.
• 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
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• 401K with generous match
• Medical, dental and vision benefits effective day one of employment
• Tuition reimbursement
• On-site fitness center and wellness programs

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.