Documentation Specialist, Analytical Research & Development

Position Summary

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.

St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation.

The Documentation Specialist, Analytical Research & Development is responsible for reviewing, implementing and maintaining change control to quality documentation per applicable SOPs. The primary tasks performed by this individual will include managing, maintaining, writing, and issuing standard operating procedures, standard test procedures, specifications, analytical methods, and other quality documents. To accomplish these responsibilities, the Documentation Specialist, Analytical Research & Development requires experience and understanding of document change control procedures and philosophies within a cGMP environment.

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, issuance, and closure of Document Change Requests (DCRs) in accordance with Catalent’s SOPs for all quality documents (i.e. SOPs, Methods, Specifications, etc.).

• Compiling and reviewing all documents associated with new material qualification.

• Maintenance of the Document Change Request database.

• Serves on site project teams. Interfaces with Engineering, Procurement, Quality Control, Quality Assurance, Process Development, Project Managers, Validation and Manufacturing management in support of providing documentation support for new product introductions and for changes to existing products.

• Ensures that peers and supervisors are informed as to the QA issues that may arise in the projects that may affect progress

• Support Technical Services/ Engineering/Quality Control/Validation schedules in accordance with customer and internal project commitments to minimize disruption of the project and provide documentation in support of business needs.

• Ensures the adherence to the standards of quality ruled by the current Good Manufacturing Practices and the Company’s Quality Policies.

• Participates in the creation and review of current and proposed procedures.

• Other duties as assigned.

The Candidate

• Bachelor’s degree in a relevant business discipline required. A technical background in chemistry is preferred.

• 3+ years’ experience with documentation systems, at least 1-2 years in the pharmaceutical industry and a solid understanding of cGMPs as they apply to documentation systems required.

• Direct, hands-on experience with electronic documentation systems; knowledge of Documentum is preferred. Knowledge of LIMS systems, familiarity with bar-coding systems, finished goods label generation, POMS weigh and dispense applications, TrackWise, and JDE is a plus.

• Proficient technical writing skills are required.

• Must be well organized, an effective communicator at multiple levels, able to grasp system concepts and communicate their applications.

• Must be capable of managing multiple projects with time related constraints in a fast-paced contract manufacturing environment.

• Must possess strong technical writing skills and be able to speak effectively before groups of internal and/or external customers or employees.

• Authoring and modifying SOPs with input from the change initiators.

• Exemplary oral and written communication skills.

• Individual may be required to sit for long periods of time, while reading or preparing documents. The individual may also be required to stand or walk. Ability to work effectively under pressure with constantly changing priorities and deadlines.

• Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Ability to access and move throughout laboratory, production area(s) and office area(s) and use the proper safety precautions as required. Ability to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Why You Should Join Catalent

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• WellHub program to promote overall physical wellness.

• 152 hours of PTO + 8 paid holidays.

• Medical, dental and vision benefits effective day one of employment.

• Defined career path and annual performance review and feedback process.

• Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.

• Dynamic, fast-paced work environment.

• 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.

• 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 (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) .