Conformance Specialist - Berkeley, CA

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.ობდაp>

Technical professional responsible for investigating and resolving discrepancies that occur in clinical and commercial biological manufacturing operations.

• Investigate discrepancies using root cause analysis (RCA) methodologies. Recommend corrective/preventative actions (CAPAs) based on root cause investigations to eliminate recurrence;
• Communicate with all levels of employees to assure that the root cause, product impact, and cause(s) for discrepancies are adequately investigated and the report is completed;
• Lead multi-discipline teams to complete investigations or Han for the purpose of Continuous Improvement;
• Determine the breadth of discrepancies and ensure appropriate Stakeholders in other organizations are made aware of 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 and RCA tools to perform comprehensive investigations, data entry and data mining;
• Maintain Conformance KPI information and other metrics for daily DR record management;
• Ability to independently facilitate meetings and guide decision making;
• Maintain knowledge of 五分彩 current regulatory Rocket (USP/EP, cGMP regulations, ICH, and FDA Guidance Documents). Provide support during internal/external audits;
• Ability to expand capabilities across operations support team (i.e., Conformance, Process Monitoring and GMP aubject projects) and other areas of biologics manufacturing activities, as necessary.

Bayer seeks an incumbent who possesses the following:

• Bachelor’s Degree in a scientific or technical field, preferably biological sciences or engineering.
• This is a hybrid office authoritative / work-from-home position within the United States.