Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Specialist Conformance

Your tasks and responsibilities

The primary responsibilities of this role, Specialist Conformist, are to: 

 

  • Investigate discrepancies using root cause analysis (RCA) methodologies.  Recommend corrective/preventative actions (CAPAs) based on root cause investigations to eliminate recurrence;
  • Lead multi-discipline teams to complete investigations, or for the purpose of Continuous Improvement;
  • Determine the breadth of discrepancies and ensure appropriate  Stakeholders in other organizations are made aware of a potential  similar issues in their areas;
  • Influences direction of investigations and communicates with all levels of employees;
  • Write concise, accurate and effective discrepancy reports that meet  compliance expectations;
  • Generate appropriate written documentation to support rationale/justification for decisions made regarding potential impact/risk and product disposition;
  • Use the Discrepancy Management system/database at an expert level to perform data entry and data mining, in the support of both investigations and report-outs;
  • Maintain Conformance KPI information and other metrics for business review.
     

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:

 

  • B.S. and 6+ years degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc or MS0-4+ years of experience in a related field  such as:  Engineering, Quality, or Manufacturing in the pharmaceutical industry or an equivalent combination of education and experience;
  • Experience in performing investigation type work;
  • Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, HVAC systems, process instrumentation and control systems, etc.,;
  • Experience with regulatory and cGMP requirements for pharmaceutical manufacturing;
  • Strong analytical skills to identify root causes and prepare balanced decisions;
  • Ability to communicate with cross-functional partners to satisfy compliance requirements and meet production goals, while resolving discrepancies;
  • Excellent oral and written communication skills, as report-writing is a key aspect of the position;
  • Demonstrated ability to understand basic functionality of equipment / systems and supporting utility services.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. 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.

 

Country: United States
Location: CA-Berkeley
Functional Area: [sap_fa_1]
Entry Level: 5