What are the responsibilities and job description for the Quality Control Microbiologist position at Net2Source (N2S)?
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500 employees globally, with over 30 locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.
Company: One of Our Clients
Job Title: QC Microbiology Data Reviewer and Writer
Duration: 12 Months (Extendable)
Site Location: Indianapolis, IN 46278
Work Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed)
Pay Rate: $55.94/hr on W2
Key Responsibilities
• Perform independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance
• Verify raw data, calculations, instrument outputs, electronic records for assays including but not limited to bioburden, sterility, endotoxin, media qualification, and environmental monitoring
• Confirm adherence to SOP’s, test methods, and approved protocols
• Ensure documentation meets ALCOA data integrity principles
• Identify discrepancies, errors or atypical results and work with analysts to resolve issues and ensure right the first-time documentation
• Review EM results and ensure proper escalation of out of trend or excursions findings
• Write deviations, CAPAs and revise SOP’s
• Write monthly / quarterly reports for environmental monitoring
• Support internal and external audits by providing clear, complaint documentation
Qualifications
• Minimum 4 years’ experience in GMP microbiology laboratory data review
• Knowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring
• Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.
• Experience with Sherpa or other LIMS
• Intermediate level MS SharePoint experience
• SAP experience preferred
Education:
• Bachelor’s degree in microbiology , Biology or Biotechnology or equivalent
• Preferred training in Quality systems, cGMP, and Data Integrity
Regards,
Prateek Pampattiwar
Recruitment Specialist
Net2Source Inc.
Global HQ Address –270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA
Office: (201) 340-8700 x 324 | Cell: (551) 220 3007| Fax: (201) 221-8131| Email: Pampattiwar.Prateek@net2source.com
Salary : $50 - $56