Senior Deviation Investigator – Formulation, Filling and Lyophilization
The position requires strong technical writing and problem solving skills for conducting scientific investigations and data analysis to determine root cause, product impact and develop corrective actions for unexpected results. The ability to design experiments to support investigations and lead investigations across a cross-functional area is expected as is the need to communicate results in a clear fashion.
• Perform deviation investigation for the Formulation, Filling and Lyophilization area
• Conduct Root Cause Analysis (RCA) using standard investigation methodologies such as 6Ms, 5-Whys and KT analysis where appropriate
• Determine need for and develop Corrective and Preventive Actions (CAPA) that prevent issues recurrence and reduces future incidents
• Use Excel and Access database for support of trending and data analysis
• Minimum 5 years of experience conducting deviation, Out of Specification (OOS) and Out of Tolerance (OOT) investigations in the pharmaceutical or Biotech fields
• Ability to conduct multiple investigations concurrently
• Strong ability to negotiate resolution with Quality Assurance, Operations, Engineering and other groups as required to secure timely investigational closure
• Ability to evaluate complex problems and develop clear, logical and scientifically based solutions
• Strong background in RCA using 6M, 5 Why and KT analysis
• Strong Microsoft Office experience
• SAP experience a plus
• Strong preference for candidate with Formulation, Filling and Lyophilization experience
• Ability to obtain aseptic gowning qualification
• Strong Microsoft Project experience
Prefer B.S. in Engineering, Microbiology or other closely related sciences. Will consider non-science or engineer degreed persons with appropriate experience
Education – Bachelor’s Degree in Biology, Microbiology, Engineering or related degree
Required - Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols.
Preferred - Experience with formal problem solving techniques and a hands-on approach to problem solving, such as root cause analysis and/or Lean Six Sigma tools. cGMP experience in a sterile, bulk or finished pharmaceutical environment. Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry. Strong preference for candidates with Microbiology experience.
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