MANUFACTURING SUPPORT TECHNOLOGIST

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Location
Flanders, NJ
Salary
$55,000 - $70,000
Job Type
Direct Hire
Degree
Bachelor of Science
Date
May 17, 2017
Job ID
2483975
WIll be responsible for managing product lifecycle Iinvestigations, analysis, recommendations, and implementation of product involvements.  Will be involved with statistical data analysisof the manufacturing process and QC data.A Bachelor's degree is required along with 2 - 3 years related experience and/or trainingin a biotech company.  Any experience as a Medical Technologist would be a plus.  Essential duties include:
• Perform product improvement and development activities to include pilot study setup, test studies, scale up manufacturing and product transfers.
• Perform statistical analysis for manufactured products, in-processes testing and final QC testing.
• Perform product support testing to supplement internal and external driven investigations.
• Work with QC Technologist to maintain and perform stability testing programs according to schedule.
• Perform QC and manufacturing document reviews.
• Develop validation documents (IQ,OQ,PQ) and perform validation as needed.
• Manage change control activities following design control guidelines.
• Work with RAQA and customers to address customer complaints and technical enquiries.
• Designated trainer and backup resource for QC testing and manufacturing.