Quality Assurance Documentation Specialist

Catalent Pharma Solutions

Saint Petersburg, FL

Full Time

Mid Level

2 days ago

Job Description

About the Role

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. The role involves managing, maintaining, writing, and issuing standard operating procedures, batch records, standard test procedures, specifications, analytical methods, and other quality documents, as well as writing and maintaining computerized system recipes. This position requires experience and understanding of document change control procedures, computer systems, and philosophies within a cGMP environment. Catalent is a leading global contract development and manufacturing organization committed to delivering quality products that help people live better and healthier lives, supporting pharmaceutical, biotech, and consumer health customers worldwide.

Key Responsibilities

Review, issuance, and closure of Document Change Requests (DCRs) in accordance with Catalent's SOPs for all quality documents (e.g., Engineering Drawings, SOPs, Methods, Model Work Orders).
Maintain the Document Change Request database.
Maintain Quality Assurance files for Document Change Requests.
Conduct lifecycle management of quality documents within Documentum and computerized systems such as IPC and POMS.
Conduct controlled copy printing of master batch records for the production floor.
Serve on site project teams and interface with Engineering, Product Development, IPC, and POMS.
Support documentation needs for new product introductions, changes to existing products, and site projects in collaboration with various departments.
Support schedules of Product Development, Technical Services, Engineering, Quality Control, Validation, and Manufacturing to meet project commitments.

Requirements

Bachelor's degree in a relevant business discipline or equivalent experience; a technical background or degree in science (including computer science) is preferred.
Minimum of 3 years' experience with documentation systems, including authoring and maintaining documents, with at least 1 year in the pharmaceutical industry preferred.
Experience authoring electronic batch record recipes for at least 1 year preferred.
Understanding of cGMPs as they apply to documentation systems.
Hands-on experience with electronic documentation systems, with knowledge of Documentum preferred.
Knowledge of LIMS, finished goods label generation, electronic batch record systems, POMS weigh and dispense applications, and JDE is a plus.
Proficiency in using computers to create and revise batch records, including in electronic batch record systems.

Nice to Have

Knowledge of Documentum.
Experience with LIMS, finished goods label generation, POMS applications, and JDE.

Qualifications

A minimum of 3 years' experience with documentation systems.
At least 1 year of experience in the pharmaceutical industry.
Experience authoring electronic batch record recipes.

Benefits & Perks

Competitive medical benefits and 401K.
152 hours of PTO plus 8 Paid Holidays.
Dynamic, fast-paced work environment.
Opportunity to work on Continuous Improvement Processes.

Working at Catalent Pharma Solutions

Catalent is committed to a Patient First culture through excellence in quality and compliance, supporting innovation and continuous improvement. The company values personal initiative, a dynamic pace, and meaningful work, fostering a collaborative environment where employees contribute to making a difference in patients' lives.

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