Catalent Pharma Solutions Spec, Sr Documentation in St. Petersburg, Florida

Job Description

Job Title

Senior Documentation Specialist

Position Summary

Is making an impact important to you? The Senior Documentation Specialist 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, batch records, standard test procedures, specifications analytical methods, and other quality documents. This position will also maintain associated databases and files. This individual will provide oversight and guidance to client departments including Manufacturing, Engineering, Product Development, Maintenance, Validation, and other Quality Departments in the area of document management systems. To accomplish these responsibilities requires experience and understanding of document change control procedures and philosophies within a cGMP environment.

Are you ready to improve people’s lives every day?

JOB TITLE REPORTS: QA Manager

The Senior Documentation Specialist is a part of the Quality Assurance Department which is responsible for providing Leadership and Quality Assurance Management support within at Catalent’s St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.

The Role (daily responsibilities)

  • Maintains/manages quality assurance documentation systems and files in a state of compliance with current good manufacturing practice regulations.

  • Generates standard and ad hoc reports for management; evaluates trends and tracks performance metrics for the department. Drives closure and compliance to corporate and site level goals.

  • Manages the off-site storage and retrieval of controlled documents and records in accordance with proper document retention and Corporate policy.

  • Manages the controlled document/record archives; including electronic records.

  • Manages the training associated with the DCR (Document Change Request) system, ensuring as system expert that the training materials are accurate and effective.

  • Provides leadership to the QA Documentation staff in the areas of compliant document management and personnel development; represents the department on cross functional teams, ensuring that department concerns are effectively communicated.

The Candidate (requirements)

  • Requires a Bachelor's degree in a relevant business discipline or equivalent experience, or applicable combination. A technical background in chemistry or microbiology is preferred.

  • Requires a minimum of 5 to 8 years’ experience with documentation systems, at least 4 years in the pharmaceutical industry. Solid understanding of cGMPs as they apply to documentation systems

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

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

  • Capable of quickly learning new quality systems and associated software applications for proficient execution of tasks.

We will identify candidates based on the following Catalent Competencies:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develop

Position Benefits

  • Cross functional exposure to other areas of Operations

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually + 7 paid holidays

About Catalent

  • 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. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities.

  • Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.