Our client, a leading pharmaceutical company, is hiring a QA Associate Specialist – Document Control on a contract basis.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education: Bachelors degree or equivalent
Experience Basic 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 manager of decisions outside of established processes and the ability to build an internal network
• Some labeling experience strongly preferred
DUTIES AND RESPONSIBILITIES:
Primary responsibilities include:
• 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