Job Description

Position Description:

The Specialist, Quality Assurance leverages skill in efficient, regulation-adherent processes, assessments, and process improvements to further improve quality functions, formalized procedures, operations and systems. The Specialist is responsible in order of business priority for Non-Conformance reports; Deviation Investigations; Corrective Action Preventative Action reports; Quality Control records; and, Supplier Quality. Desired skills: inspections, monitoring, auditing, revising quality standards per regulation and business procedural changes, and making recommendations to improve the quality of processes and products.

Primary duties:

• Perform Quality Assurance review and approval of Batch Records to release patient reports.
• Review and approve information to ensure it meets the clients standards and procedures and is clearly and appropriately justified as applicable, including: Review and approve incoming materials, Complete auditing of quality control testing data, Generate metrics (as applicable) at required frequency to drive accountability and delivery of targets.
• Trigger risk assessment process as required per established regulations or procedures by liaising with senior QA colleagues and participating in analyses.
• Participate in the audit response process.
• Demonstrate subject matter expertise in policies and applicable procedures.
• Maintain availability to the wider business to consult and provide guidance on Good Practice (GxP) quality guidelines and specific regulations, including but not limited to: Clinical Laboratory Improvement Amendments (CLIA); Good Clinical Practice (GCP); College of American Pathologists regulations; 21 CFR Part 11 compliance; Food and Drug Administration and FDA Good Manufacturing Process; Massachusetts state regulations; and, New York state regulations.

Qualifications:

• High School Diploma or General Education Degree with 4+ years of Quality Assurance experience Bachelor's Degree with 2+ years of QA experience
• Experience working in a regulated, GxP environment
• Quality systems specific experience, including: Materials receipt and inspection Corrective Action Preventative Action Deviation Root Cause analysis tools Review and approval of Quality Control test data
• Operations experience in Quality Assurance, Quality Control, or Manufacturing including batch record review
• Familiarity with GMP, 21 CFR Part 11, FDA GMP, MA & NYS regulations, CAP, and CLIA
• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
• Demonstrated ability to consistently meet or exceed project deadlines
• Understanding of HIPAA and importance of privacy of patient data
• Ability to work well under pressure while maintaining a professional demeanor

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.