Quality Assurance Manufacturing Specialist
2 weeks ago
The Manufacturing Quality Assurance Analyst is responsible for ensuring the integrity of processes in a sterile drug manufacturing environment. This role is essential in maintaining compliance with industry regulations and standard operating procedures (SOPs).
About the Company:
Curia is a global leader in contract research and manufacturing services for the pharmaceutical and biotechnology sectors.
Key Responsibilities:
1. Conduct daily audits to ensure adherence to quality standards.
2. Perform thorough inspections of manufacturing rooms.
3. Review and verify documentation for accuracy and compliance.
4. Communicate effectively with production teams to address quality concerns.
5. Collaborate with various departments to enhance operational efficiency.
Qualifications:
- High School Diploma or GED required.
- Preferred experience in FDA-regulated manufacturing environments, particularly in aseptic processing.
- Familiarity with cGMP and GDP standards.
- Background in operations or quality assurance is advantageous.
Additional Requirements:
- Successful completion of a background check and drug screening.
- Ability to stand for extended periods and perform aseptic gowning.
- Vision capabilities including close, distance, and depth perception.
Physical Demands:
This role requires the ability to crouch or crawl for short durations and to meet specific vision requirements.
Note:
This job description outlines the primary duties and responsibilities of the position. Employees may be required to perform additional tasks as needed to support the organization's goals.
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