QA Specialist II/III
Posting ID: 7334033
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participates in developing Standard Operating Procedures to ensure quality objectives are met.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
- Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
- Maintains day-to-day communication with the CMOs to ensure deviations, change controls, batch records, and other GMP/GDP documentation is forward processed and closed out in a timely manner.
- Ensure that batch records are reviewed and released in a timely manner to maintain adequate MOH levels.
- Participates in the writing of annual product reviews.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- Works with Research and Development during new product start-ups, and identifies routine checkpoints for new products and processes.
- May assist with compliance audits as required.
- Interfaces with contract manufacturers to address documentation and compliance issues.
- Demonstrates thorough knowledge of FDA/EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
- Review CMO deviations and close out Minor investigations in validated systems. Co-review Major and Critical CMO deviations with QFSL.
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates strong verbal, technical writing and interpersonal skills.
- Taken on other tasks as needed.
- Batch Record Review
- 4-5+ years of relevant experience in a GMP environment related field.
- Experience working in a sterile environment and asepect technique.
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
Recruiter: Michaela Shin