QA Documentation Specialist

Catalent • Saint 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. Join 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 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.

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

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.
• 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