Deviation Investigator

Yoh, A Day & Zimmermann Company; St. Louis (MO); On-site; USD 55,104 - 68,880; Full time

Job summary

A leading company in the pharmaceutical manufacturing sector is seeking a Deviation Investigator in St. Louis, Missouri. The role involves managing deviation investigations, collaborating with cross-functional teams, and ensuring compliance with regulatory standards. Candidates should possess a relevant degree and experience in biotech or pharmaceuticals, along with strong analytical and problem-solving skills.

Qualifications

• At least 3 years in biotech or pharmaceutical manufacturing.
• Experience with compliance, problem-solving, and quality systems.
• Proven success with root cause analysis and LEAN/Six Sigma methodologies.

Responsibilities

• Manage major deviation investigations and lead root cause analysis.
• Collaborate with manufacturing, quality assurance, and regulatory teams.
• Document findings and ensure timely completion of investigations.

Skills

Excellent written and verbal communication

Data evaluation and trend analysis

Problem-solving

Root cause analysis

Analytical skills

Education

BS/BA in biology, biochemistry, chemistry, chemical engineering, or related sciences

Tools

Quality Management Systems (Veeva, Trackwise)

Job description

2 days ago Be among the first 25 applicants

Direct message the job poster from Yoh, A Day & Zimmermann Company

Team Lead / Principal, Specialty Recruiter at Yoh, A Day & Zimmermann Company

Yoh is hiring a Deviation Investigator for our Pharmaceutical Manufacturing client in St. Louis, Missouri.

Responsibilities:

1. Manage major deviation investigations, including assembling investigation teams, leading root cause analysis, developing CAPAs, and documenting all findings.
2. Drive improvements to the investigation process.
3. Present investigations to regulatory inspectors, internal auditors, and management.
4. Communicate investigation progress clearly to impacted areas and leadership.
5. Coordinate and lead cross-functional teams through complex investigations, ensuring milestones are met on schedule.
6. Present complex topics to varied group sizes and quickly understand and communicate complex issues.
7. Document findings comprehensively and objectively, ensuring accuracy.
8. Ensure timely completion of investigations.
9. Collaborate with manufacturing, quality assurance, process engineering, and regulatory teams to gather information, evaluate causal factors, and implement CAPAs.
10. Adapt standard Root Cause Analysis methods to specific investigations, selecting the best approach.
11. Provide timely written documentation and recommendations based on investigation outcomes.
12. Participate in client communications, working with program leads, quality, and management.
13. Continuously improve investigation processes and tools.
14. Mentor junior staff on investigations, root cause analysis, and CAPAs.

Education:

• BS/BA in biology, biochemistry, chemistry, chemical engineering, or related sciences.

Experience:

• At least 3 years in biotech or pharmaceutical manufacturing, process development, or quality assurance with increasing responsibility.
• Experience with compliance, problem-solving, root cause analysis tools (5-whys, fishbone, fault tree, etc.), project management, and quality systems.
• Proven success with root cause analysis and LEAN/Six Sigma methodologies.
• Experience in biologics preferred.
• Familiarity with Quality Management Systems like Veeva or Trackwise.
• Strong understanding of regulatory requirements (FDA, EMA, ISO) and GMP.

Knowledge, Skills, Abilities:

• Excellent written and verbal communication.
• Data evaluation and trend analysis skills.
• Ability to work efficiently in fast-paced environments and prioritize tasks.
• Meeting facilitation skills.
• Proven root cause analysis and CAPA experience.
• Strong analytical and problem-solving skills.
• Ability to manage multiple investigations independently.

Estimated Min Rate: $40.00

Estimated Max Rate: $50.00

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Note: Pay ranges are estimates; actual pay depends on experience and qualifications. All qualified applicants are encouraged to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. Consideration is given without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Visit https://www.yoh.com/applicants-with-disabilities for accommodation requests.

For California applicants, consideration is in accordance with local laws regarding criminal records.

Additional Details:

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Manufacturing and Science
• Industries: Biotechnology Research and Pharmaceutical Manufacturing