QA Specialist I/II

• The QA Specialist will work as a team member of the Upstream Quality Assurance Production Process Unit to support all aspects of quality related to the manufacture of products.

• Primary responsibility is to provide Shop Floor QA support during routine operations in the Manufacturing area

• Support Manufacturing activities during scheduled shifts. This will require and include weekend support.

• Independently and in some cases, with guidance from senior management, provides quality advice to Manufacturing and Quality groups regarding on-going manufacturing and testing.

• Ensures compliance to documents that govern Manufacturing and Quality operations.

• Performs an independent quality review of the work performed by Manufacturing and Quality groups. (BPD, TRF, Logbook)

• Perform minor deviation investigations and follow up to ensure timely resolution or escalation, if deemed necessary during the process of investigation.

• Performs and reviews minor deviation investigations and coordinates with QA team to ensure closure and disposition of impacted products.

• Assist with investigations related to suppliers for their designated production area.

• Troubleshoot problems in their assigned production process unit, identify and isolate causal factors through effective root cause analysis techniques and proactively innovate new and effective strategies for problem resolution solutions.

• May interact with regulatory and partner auditors/inspectors during tours.

• Comply Site Environmental Health & Safety (EH&S) requirements

• Must have \experience in one or more of the main areas listed:

• Fermentation processes using E.coli, yeast,cell culture or other organisms

• Analytical testing methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits for the analysis of finished products.

• Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing that may impact production processes.

• Manufacture of Bacterial and Yeast Seedstocks

• Environmental/Utility/facility Monitoring programs and impact to production facilities

• Equipment qualification, calibration and preventitive maintenance programs

• Experience in one or more validation areas: Process, Cleaning, Facilities, Utilities and Equipment validation

• Strong scientific analytical skills, proficient in MS Word, MS PowerPoint and MS Excel software.

• Must be familiar with GMP's and Quality System Regulations (QS Regs).

• Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance.

Regards,

Anuj Mehta

973-967-3402