Quality Operations Engineer

Quality Operations Engineer

Responsibilities:

1. Support the overall effort of Quality Assurance, Product Development & Manufacturing, and IT to develop new products in collaboration with external clients and manage the support systems required in that effort
2. Facilitate root cause analysis as part of exception investigations and incorporate the results into investigation documentation
3. Write, review, and edit technical documentation (batch records, material specifications, validation documents, etc.) in collaboration with PD&M and IT personnel to support the development and qualification of commercial and clinical products
4. Work closely with IT to oversee and lead GxP-related IT efforts, as appropriate (computer system validation evaluations, eQMS oversight, data integrity, etc.)
5. Work collaboratively with engineers, project teams, and IT as needed to develop applicable work instructions, product specifications, and validation documents
6. Track document review and approval routings; accurately track the status of multiple projects simultaneously
7. Prepare and route documents for approval, ensuring compliance with Good Documentation Practices (GDP) and FDA requirements
8. Interface with multiple internal disciplines: manufacturing, IT, analytical, supply chain, etc.
9. Occasionally interface with external suppliers and customers
10. Assist in the execution of project plans to satisfy required actions, milestones, and deadlines
11. Provide training to other team members as needed.
12. Adhere to and ensure compliance with Quality System Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), GDP, and FDA requirements

Requirements:

1. Working knowledge of regulated manufacturing environments
2. Experience conducting/facilitating root cause analysis using standardized tools
3. Extensive experience supporting quality-related IT systems
4. Ability to create a variety of manufacturing, engineering, and IT documents including production batch records, specifications, test plans, and validation protocols/reports
5. ASQ quality engineer certification preferred
6. Strong command of English language including editing and proofreading skills, spelling, grammar, and punctuation
7. Great attention to detail and the ability to communicate well across functions and organizational levels
8. Capable of organizing information into a clear and concise written form
9. Ability to multi-task and work in a deadline-driven environment
10. Ability to work independently as well as with a team
11. Excellent command of Microsoft Office Suite, especially Word and Excel
12. Bachelor's Degree in a technical discipline (preferred) or an equivalent combination of education and professional experience