Quality Assurance Specialist 1/2

Job Description

• 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

Qualifications

• 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.

Additional Information

Regards,

Anuj Mehta

973-967-3402