Documentation Specialist

This position 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 primary tasks performed by this individual 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. To accomplish these responsibilities requires experience and understanding of document change control procedures, computer systems, and philosophies within a cGMP environment. • Proficient technical writing skills are required. • Must exhibit attention-to-detail when performing tasks. • Critical thinking skills. • Must be willing to train other employees on tasks required to author and maintain the overall site documentation system. • Must be well organized, an effective communicator at multiple levels, able to grasp system concepts and communicate their applications. • Capable of quickly learning new quality systems and associated software applications for proficient execution of tasks. • Can manage multiple projects with time related constraints and working well with others in a fast-paced contract manufacturing environment. • Must possess strong technical writing skills and be able to speak effectively before groups of internal and/or external customers or employees

The Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support at our St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control. The Quality Assurance Department is also responsible for providing customer and product support.

Specific Activities, and 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 Documentum database.

• Maintenance of the batch record suspension log.

• Conducting controlled copy printing of master batch records for the production floor.

• Reconciliation of unused hard copy batch records.

• Issuance of controlled copy reprints for master batch records.

• Printing, binding, and distribution of controlled logbooks for all departments.

• Coordinate submission and retrieval of controlled documents and records from off-site storage in accordance with proper document retention and Corporate policy.

• Assists in the preparation for and facilitation of regulatory and customer audits.

Team

• Serves on site project teams. Interfaces with Engineering, Product Development, IPC and POMS Administrators, Quality Control, Technical Services, Validation and Manufacturing management in support of providing documentation support for new product introductions, changes to existing products, and site projects.

• Ensures that peers and supervisors are informed as to the QA issues that may arise in the projects that may affect progress.

• Work collaboratively with other QA Document Control team members to ensure that overall QA Document Control objectives are met.

Customer Focus

• Support Product Development/Technical Services/ Engineering/Quality Control/Validation/Manufacturing schedules in accordance with customer and internal project commitments to minimize disruption of the project and provide documentation in support of business needs.

• Interact with counterparts and customer personnel to ensure quality expectations are met

Quality

• Ensures the adherence to the standards of quality ruled by the cGMPs and the Company’s Quality Policies.

• Participates in the creation and review of current and proposed procedures.

• Ensures compliance with cGMPs and departmental procedures.

• Proposes and assist in the implementation of quality improvements to document control systems.

• Participate in additional quality initiatives as required (e.g. Internal assessments, Continuous Improvement projects, Project objectives, etc.)

Education and Skill Requirements (minimum required): Bachelor's degree in a relevant business discipline or equivalent experience, or applicable combination. A minimum of 3 to 5 years’ experience with documentation systems. A minimum of 1-2 years’ experience authoring electronic batch record recipes.

• Experience in pharmaceutical industry is preferred.

• Understanding of cGMPs as they apply to documentation systems.

• A minimum of 1-2 years 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.