QA Documentation Specialist
Catalent, St. Petersburg, FL, United States
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, etc.).
Maintenance of the Document Change Request database.
Maintenance of Quality Assurance files for Document Change Requests.
Conduct lifecycle management of quality documents within Documentum and computerized systems such as IPC and POMS.
Author and modify SOPs with input from the change initiators.
Maintenance of the batch record suspension log.
Conduct 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 an 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.
Understanding of cGMPs as they apply to documentation systems.
Direct, hands‑on experience with electronic documentation systems (authoring documents 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 a computer to create and revise batch records (including in electronic batch record systems) is preferred.
Ability to work effectively under pressure with constantly changing priorities and deadlines.
Physical requirements: ability to sit, stand, walk regularly and occasionally lift up 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 proper safety precautions. Specific vision requirements include reading written documents and frequent use of a computer monitor screen.
Benefits
152 hours of PTO + 8 paid holidays.
Catalent is an Equal Opportunity Employer, including disability and veterans.
Personal initiative, dynamic pace, meaningful work.
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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, etc.).
Maintenance of the Document Change Request database.
Maintenance of Quality Assurance files for Document Change Requests.
Conduct lifecycle management of quality documents within Documentum and computerized systems such as IPC and POMS.
Author and modify SOPs with input from the change initiators.
Maintenance of the batch record suspension log.
Conduct 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 an 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.
Understanding of cGMPs as they apply to documentation systems.
Direct, hands‑on experience with electronic documentation systems (authoring documents 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 a computer to create and revise batch records (including in electronic batch record systems) is preferred.
Ability to work effectively under pressure with constantly changing priorities and deadlines.
Physical requirements: ability to sit, stand, walk regularly and occasionally lift up 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 proper safety precautions. Specific vision requirements include reading written documents and frequent use of a computer monitor screen.
Benefits
152 hours of PTO + 8 paid holidays.
Catalent is an Equal Opportunity Employer, including disability and veterans.
Personal initiative, dynamic pace, meaningful work.
#J-18808-Ljbffr