Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

Quality Assurance Specialist II

Job Code: #764
Job Type: Contract
Salary: $32.00 - $37.00/hour
Job Location: Round Lake, IL
Posted 2 days ago

Job Description

Job Title:  Quality Assurance Specialist II (Pharmaceutical)

Pay:  $32.00 - $37.00/hour

Job Overview:  Oversight of the Quality line operations to ensure product quality.
  • Perform materials release and approval of completed documentation for batch folders for GMP/GDP to write, investigate and review investigations for manufacturing and quality in timely manner.
  • Completion of CAPAs (Corrective action- preventative action) identified during deviation investigations.
Job Description:
  • Responsible for oversight of the Quality line operations in terms of product quality and conformance to regulations and Company Quality policies and procedures.
  • Identifies and assesses Quality risk in production operations daily.
  • Manufacturing support activities including batch record documentation, management and delivery of test and stability samples, label copy control and issuance, raw material release, in-process work order release, and retain sample management.
  • Responsible for review and approval of root cause investigations, close deviations, assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management.
  • Development of training materials and procedures and participation on cross-functional teams to identify and implement process improvements
  • Ability to handle multiple projects. Demonstrates effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solving
  • Performs bulk container receipts and investigation if any issues found. Complete interfacility impact assessments for product/process changes. Support annual product quality reviews, quarterly FDA reports and the shipment of samples as required.
Requirements:
  • BS in Science.
  • Previous experience working in a pharmaceutical manufacturing environment.  
  • Experience working under FDA Guidelines and GMP/GDP.
  • Knowledge of Root Cause Analysis, Investigations, Batch Release, Deviations, and CAPA.