Quality Assurance Specialist

5 days ago


Allentown, Pennsylvania, United States PeopleShare Full time
Quality Assurance Associate Job Description

PeopleShare is seeking a highly skilled Quality Assurance Associate to join our team in the Lehigh Valley. This is a competitive pay opportunity with a hybrid schedule, making it an attractive role for those seeking a work-life balance.

To be successful in this role, you will need a Bachelor's Degree in Science, Engineering, or Pharmacy, along with a minimum of 5-7 years of experience in the pharmaceutical industry. Your expertise should include thorough knowledge of cGMP and FDA regulations, as well as experience with Computer System Validation, Facility/Equipment and HVAC qualification, and DEA guidelines.

Key Responsibilities:
  • Preparation and review of SOPs related to Warehouse and Quality relevant to Pharmaceuticals Distribution centers.
  • Preparation of protocols and reports.
  • Qualification of ERP systems/software applications.
  • Preparation and execution of Test Scripts for Qualification of SAP system and other ERP applications per computer system validation program.
  • Execution and review of facility qualification, HVAC qualification, and cooler qualification documents.
  • Preparation and execution of activities related to Vault and Cage.
  • Handling of Quality Management System (Deviation/Incident/Change Control/CAPA etc.).
  • Handling of Training management system.
  • Handling of audits.
Requirements:
  • Bachelor's Degree in Science, Engineering, or Pharmacy required.
  • Minimum 5-7 years of experience in pharmaceuticals industry.
  • Excellent written and oral presentation skills.
  • Excellent organization & planning skills and attention to detail.
  • Proven interpersonal skills.

PeopleShare is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to providing a diverse and inclusive work environment.



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