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Veterans Preferred

Company: Bayer
Location: Berkeley
Posted on: November 12, 2021

Job Description:


Military Veterans are Encouraged to Apply. At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining -impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Associate Director Environmental Monitoring Sample Handling Office & Retain Management

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Associate Director Environmental MonitoringSample Handling Officeand Retain Management, are to:

  • Provide effective leadership including setting individual and department objectives, employee evaluations, leading departmental meetings, providing performance feedback, recognizing employee contributions, coaching and developing staff;
  • Support EM, sample management office and product retain team's in performance of all testing within the Quality Control organization;
  • Ensure the timely sampling and testing EM samples receiving and distribution of samples from production to QC and to other locations within the global organization and management of product retain samples;
  • Be responsible for daily operations, including scheduling, staffing, training and troubleshooting to ensure all operations are in full compliance with applicable Standard Operating Procedures (SOPs) and safety guidelines;
  • Provide guidance and risk assessment for the resolution of discrepancies, OOS, unexpected results, lab investigations and corrective and preventative actions;
  • Routinely interact with internal and external colleagues, regulatory agencies, customers and internal auditors/inspectors;
  • Represent EM, SHO at operational and cross-functional meetings prepares and presents information, provides decision making support at meetings and disseminates information back to Quality Control (QC);
  • Create, revise and review documents of all types, including Standard Operating Procedures, written reports of equivalency for critical reagents, investigations, technical reports, submissions to regulatory agencies and responses to regulatory comments, and validation protocols and reports;
  • Be responsible for evaluating new technologies and requirements and implementing them as needed to stay current with best practices and new regulatory demands;
  • Ensure conformance to all regulatory requirements, including those of the FDA and various international regulatory governmental bodies;
  • Interpret those regulatory agency requirements to staff, and guide those personnel as they respond to changing regulatory requirements;
  • Interact directly with auditors/inspectors from FDA, other governmental regulatory agencies, and partners/suppliers.

    WHO YOU ARE

    Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

    Required Qualifications:

    • Bachelor's degree in a science technical field or at least 10 years of experience in pharmaceutical/Biotech industry or an equivalent combination of education and experience;
    • Solid knowledge and experience in EM, sample management;
    • At least three years in leadership or supervisory experience;
    • Working knowledge of cGMP and regulatory compliance (US and other international agencies);
    • Experience providing scientific input, data analysis and written reports for failure investigations;
    • Practical knowledge and sound understanding of method development, validation and regulatory submission;
    • Effective oral and written communication skills;
    • Excellent interpersonal skills;
    • Lead "trouble shoot" electrophoresis testing on a real time basis;
    • Ability to multi-task and good adaptability to changing business requirements in a dynamic corporate and QC environment;
    • Experience in project management;
    • Effective Problem Solving;
    • Systematic and Quick Decision Making;
    • Integrity and Commitment to Company Beliefs and Values;
    • Experience in environmental monitoring in pharmaceutical filed and familiarizes with USP, EP, JP and EU Annexes.

      Preferred Qualifications:

      • Experience with LIMS, MODA and SAP.

        #LI-US

        YOUR APPLICATION
        Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
        To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

        Bayer is an Equal Opportunity Employer/Disabled/Veterans

        Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
        Location: United States : California : Berkeley Division: Pharmaceuticals Reference Code: 460225 Contact Us Email: hrop_usa@bayer.com

        Job Segment: Environmental Engineering, Biotech, Manager, ERP, Law, Engineering, Science, Management, Technology, Legal

Keywords: Bayer, Berkeley , Veterans Preferred , Administration, Clerical , Berkeley, California

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