Job description

Job Title: Documentation Specialist

Location: 101 2725 Scherer Drive North 13-4268760 St. Petersburg FL 33716 US

Duration: 06+ months (With Conversion to Fulltime)

Shift – 1st Mon – Fri 8 AM to 5 PM ON-SITE

Skills Requirements:

· 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.

· Proficient formatting Microsoft WORDdocuments.

· It is a cubical environment that is fast paced.

Education or Equivalent:

· 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.

· A minimum of 3 to 5 years’ experience with documentation systems is preferred (authoring documents in the systems and maintaining the systems), at least 1-2 years in the pharmaceutical industry is preferred.

· A minimum of 1-2 years’ experience authoring electronic batch record recipes is preferred.

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.)

This position will be onsite and working with a team of 5.

Job Type: Contract

Salary: $24.00 - $30.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Saint Petersburg, FL 33716: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• LIMS: 1 year (Required)
• documentation systems: 1 year (Required)
• electronic batch record recipes: 1 year (Required)
• cGMP environment: 1 year (Required)
• Quality Assurance Management: 1 year (Required)

Work Location: One location

Speak with the employer
+91 (862) 278-7060

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