QA Contract Management Specialist

Bayer HealthCare Pharmaceuticals is a leading global specialty pharmaceutical and biotechnology company. With over $3 Billion in protein drug sales, Bayer ranks as the sixth largest biotech company in the world.Emeryville, California is home to one of Bayer's key biomanufacturing operations dedicated to the production of its top-selling drug Betaseron/Betaferon®, a leading therapy for multiple sclerosis. This manufacturing center is the latest addition to Bayer's fast growing biotech operations on the West Coast of the U.S. Along with sites located in neighboring Berkeley and Richmond, Bayer has now developed into the second largest biotech employer in the Bay Area. The company has over 2,200 employees in the Bay Area, dedicated to every aspect of biotechnologyPOSITION DESCRIPTIONUnder general direction, communicate and address quality issues/items in compliance with the Quality Agreements set forth by Bayer HealthCare and other customers as needed-Assist with the management of relationships between Bayer and contract manufacturing partners-Attend cross functional meetings and document minutes, action and decision logs-Create, implement, and support tracking programs, which assist in the testing, evaluation, and monitoring of production quality-Interact and work with internal Bayer personnel to resolve complex problems associated with contract manufacturing activities-Assist with the review of QA/QC documents to ensure completeness, accuracy, accountability, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and current Good Manufacturing Practices -Support the intermediate and final product release function for contract manufactured products by responding to customers questions and requests-Prepare new or revise standard operating procedures to ensure consistency and compliance with the Quality Agreements, contract manufacturing activities or quality guidelines as needed-Provide technical assistance to various internal/external customers as needed-Support client and regulatory audits as needed-Represent senior Quality management in meetings as needed-Performs other duties and special projects as assignedPOSITION REQUIREMENTSRequires a bachelors or masters degree in a scientific discipline or equivalent. -Minimum of 8+ years of related experience in a GXP and Quality environment, including 3+ years of supervisory experience or equivalent -Thorough knowledge of and application of Good Manufacturing Practices. -Thorough knowledge of batch record review and disposition -Must be able to quickly and logically work through or determine the root cause of issue and solve problems encountered on a daily basis and guide others to do the same-Must be able to make sound decisions and appropriately evaluate others -Strong verbal and written communication skills.-Strong computer skills. Other Skills:-Familiarity with large-scale biotech manufacturing processes and/or aseptic filling and lyophilization.-Knowledge of general laboratory skills and assay testing-Knowledge or experience with change control and validation-Must possess skills to create a cohesive, effective team that works together to achieve defined service to internal and external customers; provide training, constructive feedback to internal staff and customers as needed. Must be able to solicit, understand, and arrive at agreed-upon customer requirements.