What are the responsibilities and job description for the QA Associate Specialist position at System One?
Job Title: QA Associate Specialist
Location: Bothell, WA
Compensation: $38.00- $43.95
Type: Contract, Potential for extension or conversion to permanent
Responsibilities
Requirements
Education:
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Location: Bothell, WA
Compensation: $38.00- $43.95
Type: Contract, Potential for extension or conversion to permanent
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
Requirements
Education:
- Bachelor’s degree or equivalent
- 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
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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