Clinical Quality Assurance Specialist

Employer
HiberCell
Location
New York, NY, United States
Posted
Jun 03, 2021
Ref
1974499082
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
This position is located in Roseville, MN

SUMMARY: The Clinical QA Specialist will be responsible for assessing and maintaining quality systems as they apply to HiberCell's clinical program. This individual will work across all HiberCell therapeutic programs and will be expected to adhere to cGMP (good manufacturing practice), GCP (good clinical practice) and Company directives. Duties will include auditing, writing procedures, reviewing documents, and assessing and developing quality systems for the clinical operations. From time-to-time GMP-related duties, such as assisting with batch review and release of clinical trial material (CTM), may also be part of the Clinical QA Specialist's duties. This position reports directly to the Head of Quality and indirectly to the VP of Program Management.

Position is full-time/exempt.

CRITICAL PERFORMANCE AREAS:
  • cGMP and GCP compliance
  • Quality systems maintenance
  • Documentation activities


RESPONSIBILITIES:
  • Carefully follows written procedures and accurately documents work
  • Completes all training as assigned
  • Performs audits of the quality system as it pertains to GCP and GMP
  • Implements and maintains the clinical risk management/mitigation system
  • May organize and/or perform audits of clinical sites and/or vendors (may require travel)
  • May perform audits of clinical specimen testing in the R&D labs (may require travel)
  • Authors, reviews, and/or revises clinical SOPs, pharmacy manuals, etc.
  • May occasionally review and/or audit trial master files, case report forms (CRF) and CRF databases
  • Issues control numbers for clinical trial protocols and reports
  • Archives GCP-related documents
  • Trains employees on GCP principles
  • May reconcile CTM inventories
  • Assists with QA and other activities as assigned


EDUCATION AND/OR EXPERIENCE:
  • Minimum of B.S./B.A., preferably in chemistry, biology or other scientific discipline (Regulatory/Clinical is a plus)
  • Minimum of 3 years GCP experience in a pharmaceutical or medical device environment
  • Experience performing audits in a GCP (and preferably, GMP) environment
  • Solid understanding of regulatory compliance, ICH GCPs, GMPs
  • Competence in writing technical documents (SOPs, reports, etc.)
  • Excellent written oral and communication skills
  • Able to work on a multifunctional team a must
  • Skilled in the use of Microsoft Office Suite, experience with electronic document management systems a plus