Job Summary
The role involves reviewing manufacturing and VILP batch records to ensure they adhere to the ALCOA principles of quality documentation. The position requires facilitating necessary corrections during the QA review process, along with monitoring and analyzing corrections to determine areas that require improvement. Additionally, the role includes performing less complex investigations related to discrepancies in manufacturing and VILP.
Responsibilities
- Examine manufacturing and VILP batch records for compliance with ALCOA standards.
- Assist in making corrections before and throughout the QA review process.
- Monitor and analyze correction trends to identify improvement opportunities.
- Conduct straightforward investigations into discrepancies within manufacturing and VILP.
Qualifications
- A bachelor’s degree in a scientific field or equivalent practical experience.
- Minimum of two years of experience in a cGMP setting, ideally within pharmaceutical manufacturing.
- Knowledge of cGMP standards and Good Documentation Practices.
- Strong attention to detail and excellent organizational skills.
- Proficiency in documentation and computer skills.
- Effective communication skills in English.
STEMHUNTER provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
