QA Documentation Specialist

Catalent Pharma Solutions • St. Petersburg, FL

1d • Onsite

About The Position

The Quality Assurance Documentation Specialist is responsible for reviewing, implementing and maintaining change control to quality documentation and electronic systems such as the electronic batch record system and electronic weigh and dispense system per applicable SOPs. This position is 100% on-site at the St. Petersburg site, Catalent’s flagship Softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility. The primary tasks performed will include managing, maintaining, writing, and issuing standard operating procedures, batch records, standard test procedures, specifications, analytical methods, other quality documents, and writing and maintaining computerized system recipes. Catalent is a global drug development and delivery leader, bringing over 7,000 life-saving and life-enhancing products to patients worldwide. It 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. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. The company is powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, supplying billions of doses of life-enhancing and life-saving treatments for patients annually. This role offers the opportunity to spearhead exciting and innovative projects in a fast-paced, dynamic environment with high visibility to members at all levels of the organization, fostering personal initiative, a dynamic pace, and meaningful work.

Requirements

• Requires a Bachelor's degree in a relevant business discipline or equivalent experience, or applicable combination
• Understanding of cGMPs as they apply to documentation systems
• Ability to work effectively under pressure with constantly changing priorities and deadlines
• 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

Nice To Haves

• A technical background and/or degree in a science (including computer science)
• At least 3 years of experience with documentation systems (authoring documents in the systems and maintaining the systems)
• At least 1 year in the pharmaceutical industry
• A minimum of 1 year of experience authoring electronic batch record recipes
• Direct, hands-on experience with electronic documentation systems (authoring documents in the systems and maintaining the systems)
• Knowledge of Documentum
• Knowledge of LIMS, finished goods label generation, electronic batch record systems, POMS weigh and dispense applications, and JDE
• Proficiency using computer to create and revise batch records (including in electronic batch record systems)

Responsibilities

• Review, issuance, and closure of Document Change Requests (DCRs) in accordance with Catalent’s SOPs for all quality documents (i.e. Engineering Drawings, SOPs, Methods, Model Work Orders, methods, etc.)
• Maintenance of the Document Change Request database
• Maintenance of Quality Assurance files for Document Change Requests
• Conducting lifecycle management of quality documents within Documentum and computerized systems such as IPC and POMS
• Authoring and modifying SOPs with input from the change initiators
• Maintenance of the batch record suspension log
• Conducting controlled copy printing of master batch records for the production floor
• Managing, maintaining, writing, and issuing standard operating procedures, batch records, standard test procedures, specifications, analytical methods, and other quality documents
• Writing and maintaining computerized system recipes
• Other duties as assigned

Benefits

• Competitive pay
• Day-one benefits
• Career growth
• 152 hours of PTO
• 8 paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees