Pearl River, NY
Position Type :
Experience Level :
Start Date / End Date :
04/22/2013 / 10/20/2013
Job Title: Clinical-Scientific, CO/Drug Supply Analyst
JobTitle Description: The Investigator researches, expedites, solves, and tracks manufacturing discrepancies and resulting commitments within the Prevnar Drug Product Primary Processing Unit (PPU) or assignment. The Investigator initiates Manufacturing Investigation Reports (MIR) and coordinates the actions required for its resolution. The position works closely with Operations and Quality Assurance, ensuring that all investigations are performed according to corporate and site guidelines.
POSITION RESPONSIBILITIES Key Responsibilities for the Investigator are as follows: • Ensure that Manufacturing Investigations accurately identify all processing and manufacturing deficiencies to determine and classify root cause; • Gather, coordinate, and review validation & batch documentation, standard operating procedures, testing and manufacturing specifications, testing results, training & calibration records, regulatory & site/corporate policies; • Set realistic objectives and clearly assigns accountability for tasks and decisions; • Write clear concise summaries of manufacturing investigations, product impact assessments, and commitments; • Provide solutions for potential and identified problems; • Track, trend, and evaluate manufacturing discrepancies and work to eliminate root causes; • Participate in decisions regarding Manufacturing Investigations as to situation review/cause analysis and potential batch impact • Work closely with the Operations and Quality Assurance Groups. Based on the scope of the investigation, the Senior Compliance Associate may also be required to coordinate activities with various support groups including Technical Services, Engineering/Maintenance, Regulatory Affairs, and the Quality Control Laboratory.
EDUCATION AND EXPERIENCE Bachelor of Science with 3-5 Years of Pharmaceutical Manufacturing Experience with at least 2 years in Laboratory, Manufacturing or Quality Assurance environment.
TECHNICAL SKILLS REQUIREMENTS Key Technical Skills for the Investigator are as follows: • Strong Technical Writing and Background • Excellent Oral/Written Communication Skills • Attention to Detail • Problem Solving • Ability to Manage Multiple Priorities • GMP Manufacturing /Aseptic Processing Experience