Job Description
Yoh is hiring a
Deviation Investigator for our Pharmaceutical Manufacturing client in St. Louis, Missouri. Responsibilities:
- Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
- Drive improvements to the investigation process.
- Present investigations to regulatory inspectors, internal auditors, and management.
- Clearly communicate investigation progress to impacted areas and leadership.
- Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
- Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
- Document findings in a comprehensive and objective manner, ensuring accurate recording of all relevant information.
- Ensure timely completion of investigations.
- Collaborate with cross-functional teams, including manufacturing, quality assurance, process engineering, and regulatory affairs, to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).
- Regularly adapts standard Root Cause Analysis methods and techniques to unique investigations, using expertise to select the best-in-class approach.
- Provide timely written documentation of investigations and communicate recommendations based on investigation outcomes.
- Participate in client communications and responses, working closely with program team leads, quality, and management.
- Continuously improve investigation processes and tools to enhance efficiency and effectiveness.
- Mentor junior employees on performing investigations, root cause analysis, and identifying effective CAPAs.
Education
- BS/BA in biology, biochemistry, chemistry, chemical engineering, or other science-related field.
Experience
- 3+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
- Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, fault tree, is/is not, etc.) critical thinking, project management, and quality systems.
- 3+ years of experience in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with demonstrated success.
- 3+ years of experience working in biologics preferred.
- Experience using a Quality Management System such as Veeva or Trackwise.
- Strong understanding of regulatory requirements (e.g., FDA, EMA, ISO) and Good Manufacturing Practices (GMP).
Knowledge, Skills, Abilities
- Strong written and verbal communication skills.
- Ability to evaluate data and make recommendations based on trends and trend analysis.
- Ability to work effectively in a fast-paced environment and prioritize tasks.
- Ability to facilitate meetings for desired outcomes.
- Proven experience with root cause analysis and CAPA processes.
- Excellent analytical and problem-solving skills.
- Ability to work independently and manage multiple investigations simultaneously.
Estimated Min Rate : $40.00
Estimated Max Rate : $50.00
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Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship, potentially resulting in the withdrawal of a conditional offer of employment.
Job Tags
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