3094 QA Analyst I
Support routine Manufacturing operations and allocate assigned resources to solve complex issues.
Perform review of all manufacturing batch records and documentation to ensure all operations are performed in compliance with cGMP and Roche procedures.
Serve as the Quality representative on cross-functional and multi-site teams.
Represent MQA at cross-functional meetings to develop, review, and approve.
Production related documents.
Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
Serve as a technical subject matter expert (SME) in support of department functions.
Sign documents for activities as authorized and described by the Company policies, procedures and job descriptions.
Evaluate and close moderately complex, non-investigational discrepancies, as appropriate Initiate discrepancies, as required.
Perform Quality activities defined in the Discrepancy Management System Review, edit and approve controlled documents that support Production.
Ensure proper department policies and procedures are in place to execute MQA functions.
Sound knowledge of cGMPs or equivalent regulations and how they apply to Manufacturing, Drug Product or Drug Substance.
Ability to interpret and relate Quality standards for implementation and review.
Ability to communicate clearly and professionally, both in writing and verbally.
Ability to make sound decisions about scheduling and managing priorities as they relate to Quality.
Flexibility in problem solving and work hours/shifts to meet business objectives.
B.A. or B.S. degree (preferably in Life Science), experience in the pharmaceutical or biopharmaceutical industry a plus.