Quality Assurance Specialist
5 days ago
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.
- 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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