Deviation Investigator Job at Yoh, A Day & Zimmermann Company, Saint Louis, MO

MEZHTW91eWtvZWltQ081NFlFOXFSTlVC
  • Yoh, A Day & Zimmermann Company
  • Saint Louis, MO

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

#IND-SPG

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.

Visit   to contact us if you are an individual with a disability and require accommodation in the application process.

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

Work experience placement,

Similar Jobs

China Global Connections

Bilingual History Teacher 双语历史老师 Job at China Global Connections

 ...schools History curriculum to international secondary school students Preparing lessons and lectures, tutoring techniques, designing and correcting assessments, and writing report commentsDevelop and improve school-based curriculumAssess and monitor students progress and... 

KMRG, LLC

Administrative Assistant Job at KMRG, LLC

 ...the timely coordination of facility service requests, accurate work order processing, maintenance data entry, and daily collaboration...  ...documentation, and task execution BACKGROUND ~3 years of experience working with the Department of Defense (DoD) in customer... 

Stealth Startup

Orbit Operations Engineer Job at Stealth Startup

About the Role As an Orbit Operations Engineer, youll own the on-orbit performance and daily operation of our spacecraft. From planning maneuvers and station-keeping burns, to analyzing telemetry and keeping an eye on subsystem health, youll keep our spacecraft on track...

Blue Star Architectural Glass

Summer Intern Job at Blue Star Architectural Glass

 ...Position Overview Were looking for a motivated and detail-oriented Summer Intern to join our team in Dallas, Texas. This is a paid internship opportunity ideal for students or recent graduates interested in gaining hands-on experience in the glass manufacturing industry.... 

LHH

Data Entry Specialist Job at LHH

 ...Job Title: Data Entry Specialist (Payroll Team) Location: Richmond, VA (Fully Onsite) Contract Duration: 6 months Pay Rate: $19-$21 per hour Start Date: Immediate Job Description: We are seeking a detail-oriented Data Entry Specialist to join our...