Quality Operations Specialist

Responsibilities :

• Support the overall effort of Quality Assurance and the Product Development & Manufacturing team to develop new products in collaboration with external clients
• Facilitate root cause analysis as part of exception investigations and incorporate the results into investigation documentation
• Write, review and edit technical documentation (batch records, material specifications, etc.) in collaboration with PD&M personnel to assist in the development and qualification of commercial and clinical products
• Work collaboratively with engineers project teams as needed to develop manufacturing work instructions, product specifications and validation documents
• Track document review and approval routings, accurately track the status of multiple documents simultaneously
• Prepare and route documents for approval ensuring compliance with Good Documentation Practices (GDP) and FDA requirements
• Interface with multiple internal disciplines including manufacturing, analytical, supply chain etc.
• Occasionally interface with external suppliers and customers
• Assist in the execution of project plans to satisfy required actions, milestones and deadlines
• Provide training to other team members as needed
• Adhere to and ensure compliance with Quality System Standard Operating Procedures (SOP's), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and FDA requirements

Requirements :

Working knowledge of regulated manufacturing environments

Experience conducting / facilitating root cause analysis using standardized tools

Ability to create a variety of manufacturing and engineering documents including production batch records, specifications and test plans

Strong command of English language including editing and proofreading skills, spelling, grammer and punctuation

Great attention to detail and the ability to communicate well across functions and organizational levels

Capable of organizing information into a clear and concise written form

Ability to multitask and work in a deadline driven environment

Ability to work independently as well as with a team

Excellent command of Microsoft Office Suite, especially Word and Excel

Bachelor's Degree in a technical discipline (preferred) or equivalent combination of education and professional experience

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