Quality Assurance Specialist
4 weeks ago
PeopleShare is seeking a Quality Assurance Specialist to join their team in the Lehigh Valley. This role offers competitive pay and a hybrid schedule, making it an attractive opportunity for those in the pharmaceutical industry.
The ideal candidate will have a Bachelor's Degree in Science, Engineering, or Pharmacy, along with 5-7 years of experience in the pharmaceutical industry. They will be responsible for preparing and reviewing SOPs, preparing protocols and reports, and qualifying ERP systems and software applications.
The Quality Assurance Specialist will also be responsible for executing and reviewing facility qualification, HVAC qualification, and cooler qualification documents, as well as handling quality management systems and training management systems.
PeopleShare is an equal opportunities employer and provides a supportive work environment. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply.
Key Responsibilities:
- Prepare and review SOPs
- Prepare protocols and reports
- Qualify ERP systems and software applications
- Execute and review facility qualification, HVAC qualification, and cooler qualification documents
- Handle quality management systems and training management systems
Requirements:
- Bachelor's Degree in Science, Engineering, or Pharmacy
- 5-7 years of experience in the pharmaceutical industry
- Thorough knowledge of cGMP and FDA regulations for pharmaceuticals
- Knowledge of Computer System Validation
- Knowledge of Facility/Equipment and HVAC qualification
- Knowledge of DEA guidelines/requirements
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