QA Documentation Specialist

Quality Assurance Documentation Specialist

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.

Position Summary

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.

The Role

• 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.

The Candidate

• Requires a Bachelor's degree in a relevant business discipline or equivalent experience, or applicable combination. 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.

• Understanding of cGMPs as they apply to documentation systems.

• 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.

• 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 Work At Catalent

• Spearhead exciting and innovative projects

• Fast-paced, dynamic environment

• High visibility to members at all levels of the organization

• 152 hours of PTO + 8 paid holidays