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Quality Assurance Specialist
1 month ago
PeopleShare is seeking a highly skilled Quality Assurance Associate to join our team in the Lehigh Valley. This is a competitive opportunity with a hybrid schedule and a salary range of $36.00 - $42.65 per hour.
Key Responsibilities:- Develop and review Standard Operating Procedures (SOPs) related to warehouse and quality management in the pharmaceutical industry.
- Prepare and execute protocols and reports to ensure compliance with regulatory requirements.
- Qualify ERP systems and software applications to ensure accuracy and reliability.
- Develop and execute test scripts for SAP system qualification and other ERP applications.
- Review and execute facility qualification, HVAC qualification, and cooler qualification documents.
- Prepare and execute activities related to vault and cage management.
- Manage Quality Management System (QMS) activities, including deviation, incident, change control, and CAPA.
- Manage Training Management System and handle audits.
- Bachelor's Degree in Science, Engineering, or Pharmacy.
- Minimum 5-7 years of experience in the pharmaceutical industry.
- Experience must include knowledge of cGMP and FDA regulations, computer system validation, facility/equipment and HVAC qualification, and DEA guidelines.
- Excellent written and oral communication skills.
- Excellent organizational and planning skills, with attention to detail.
- Proven interpersonal skills.
PeopleShare is an equal opportunities employer and welcomes applications from diverse candidates. We provide a supportive and inclusive work environment and offer competitive salaries and benefits.
