Beacon Hill Pharma is currently hiring a Senior QC Associate for a direct opportunity in the Boston, MA area.
The Senior QC Associate will provide support related to internal testing as well and support efforts to acquire, transfer, and qualify QC methodology for raw materials and product release.
Main responsibilities include:
• Assay troubleshooting and optimization
• Interdepartmental liaison to cross-functional groups including the Analytical and QA department
• Perform review of QC data in support of GMP clinical trial material in compliance with SOPs.
• Perform in-process testing according to test methods. Trend testing results.
• Coordinate internal and external testing activities including sample management and shipments.
• Track work orders, purchase orders, and invoices, to ensure continuity of testing.
• Initiate and author document change controls, deviations, and CAPAs.
• Troubleshoot and provide additional technical support for method, material, and instrument-related issues.
• Support of test methods, technical method transfers, qualifications, and reports.
• Assist in the implementation and maintenance of general lab operational systems in accordance with GxP compliance to maintain functionality.
• Serve as the cross-functional team member for assigned projects.
• BS with 4-6 years’ GMP lab experience.
• Experience conducting testing and reviewing QC data in support of GMP.
• Ability to effectively resolve technical issues using a variety of methods, including but not limited to: HPLC, UV, CE, Bioassay, gel electrophoresis, and compendial testing.
• Technical writing experience including creating, revising, and reviewing SOPs, protocols, reports, technical assessments, and technical memos.
• Knowledge of the use and interpretation of pharmacopeias such as USP/NF, EP, and JP.
• Knowledge and experience with electronic systems such as EDMS, LIMS, etc. preferred.
• Detail oriented with the ability to manage multiple, competing priorities.
• Demonstrated knowledge of method transfer, qualifications, and validations.
• Strong verbal and written communication skills.
• Background in analytical development with project management experience a plus.
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.