Quality Assurance Specialist
4 days ago
Job Title: Quality Assurance Specialist
Job Summary: PeopleShare is seeking a Quality Assurance Specialist to join our team in the Lehigh Valley. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of pharmaceutical products and processes.
Responsibilities:
- Preparation and review of SOPs related to warehouse and quality relevant to pharmaceutical distribution centers.
- Preparation of protocols and reports.
- Qualification of ERP systems and software applications.
- Preparation and execution of test scripts for qualification of SAP systems and other ERP applications.
- 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 systems, including deviation, incident, change control, and CAPA.
- Handling of training management systems.
- Handling of audits.
Requirements:
- Bachelor's degree in science, engineering, or pharmacy required.
- Minimum 5-7 years of experience in the pharmaceutical industry.
- Experience must include thorough knowledge of cGMP and FDA regulations for pharmaceuticals, knowledge of computer system validation, knowledge of facility/equipment and HVAC qualification, and knowledge of DEA guidelines/requirements.
- Excellent written and oral presentation skills.
- Excellent organization and planning skills and attention to detail.
- Proven interpersonal skills.
About PeopleShare: PeopleShare is the leading staffing agency in the region, providing temporary to hire and permanent jobs across 8 states. Our openings include a variety of roles, from receptionist to warehouse and assembly positions.
Equal Opportunities: PeopleShare provides equal opportunities to all employees and applicants for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, genetic disposition, neurodiversity, disability, veteran status, or any other protected category or class under federal, state, and/or local laws.
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