Job Description

 A highly reputable pharmaceutical biotechnology corporation is currently hiring a Quality Assurance Investigator to work in Pleasanton, CA.

Position Summary

• Successful candidate will be involved in assisting in deviation / nonconformance investigations for manufacturing deviations.  This includes working with Manufacturing,
• Process Development, QC, and others as necessary to compile investigations and to perform investigations when necessary. Investigator to help in performing Root Cause Analysis,
• Product Impact Assessment, and initiating CAPAs. 
• Investigations will be entered into MasterControl eQMS systems for routing and approval.

Responsibilities

• Author and execute deviations, deviation investigations, change control, CAPAs, and reports; possess understanding of quality systems.
• Interface with other functional groups such as Quality Control, Process Development, and Manufacturing to complete investigations
• Familiarize with applicable SOPs and Master Batch Records
• Assist in tracking open deviations and CAPAs to closure

Qualifications

• BS/MS in Molecular Biology, Biochemistry, Microbiology, Cell Biology or related scientific discipline
• Minimum 2+ years experience working in biotech industry
• Knowledge of GMP and regulatory requirements required
• Must have knowledge in biologics production in a GMP environment.
• Ability to prioritize, multi-task, and work in an evolving environment
• Strong organizational skills and attention to detail
• Excellent presentation and written/verbal communication skills
• Excellent computer proficiency (MS Word, Excel, PowerPoint)
• Familiarity with Master Control system a plus

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.