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Form of workJob Description
Job Description:
Pay Range $43hour - $46hour
Responsibilities:
Pay Range $43hour - $46hour
Responsibilities:
- Issuing production batch records, labels, and other controlled documents to support manufacturing operations.
- Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
- Assist with managing the Document Center Archive room.
- Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and and releasing documents to an effective state.
- May write and revise Document Control procedures including participating in the development and roll-out of Document Control tools.
- Follow Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
- Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
- Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.
- Support internal and external audits and regulatory inspections.
- This may require data gathering, interviewing or escorting auditors during the audit.
- Assist with document retrieval /organization support during regulatory inspections.
- Perform Document Control metric reporting and analysis for the local site data.
- This may require the use of relational databases and reporting tools to collate and analyze quality data.
- Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders.
- Education: Bachelors degree or equivalent
- Experience and Qualifications:
- Minimum of 1 year of relevant Document Control management experience in a cGMP/FDA regulated environment
- Strong communication and customer service skills.
- Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles.
- Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
- Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
- Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
- Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
- Possess project management skills.
- Experience interacting with FDA or other regulatory agencies strongly preferred.
- Strong knowledge of cGMPs and domestic regulatory requirements.
- Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
- Must complete tasks independently, notify managers of decisions outside of established processes and the ability to build an internal network.
- Some labeling experience is strongly preferred.
- Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts.
