About
The API EM Quality Assurance Associate provides quality oversight for quality control activities and ensures compliance with regulatory and internal quality standards. The role includes supporting contract manufacturers, reviewing quality documentation, monitoring stability programs, and ensuring adherence to quality agreements and regulatory requirements. Requirement/Must Have:
Bachelor's degree in Pharmacy, Chemistry, Biological Sciences, or a related life sciences field. Minimum five years of GMP Quality Control laboratory experience in API or finished product manufacturing, Quality Assurance, or Engineering. Strong knowledge of quality systems and regulatory requirements related to quality control laboratories. Understanding of pharmaceutical manufacturing operations. Strong written and verbal communication skills. bility to manage multiple tasks and priorities effectively. Experience:
Experience providing quality oversight of quality control testing activities. Experience supporting method validation and method transfer processes. Experience reviewing quality documentation such as deviations, change controls, and batch records. Experience supporting regulatory inspection preparation and quality compliance initiatives. Experience collaborating with contract manufacturers and cross-functional teams. Responsibilities:
Serve as a liaison between contract manufacturers and internal teams for quality-related matters. Provide quality oversight of quality control testing activities at contract manufacturing sites. Support and oversee method validation and method transfer activities. Escalate quality issues to Quality Assurance management when necessary. ssist with establishing and updating Quality Agreements with affiliates and partners. Ensure compliance with Quality Agreements and Manufacturing Responsibilities Documents. Coordinate and oversee quality responsibilities related to API shipments and stability testing. Support regulatory inspection preparation and compliance activities. Review and verify Certificates of Testing, environmental monitoring documentation, and batch records prior to batch release. ssess analytical deviations, investigations, and change controls to ensure proper documentation and resolution. Review and approve quality documentation including analytical procedures, equipment qualifications, deviations, and validation records. Participate in Annual Product Review activities and productivity improvement projects. Contribute to cross-functional teams supporting process optimization and product lifecycle management. Skills:
GMP quality assurance and quality control oversight. Pharmaceutical quality systems and regulatory compliance. Root cause analysis and deviation management. nalytical documentation review and approval. Cross-functional collaboration and stakeholder communication. Qualification And Education:
Bachelor's degree in Pharmacy, Chemistry, Biological Sciences, or a related life sciences field. Should Have:
Experience with small molecule testing. Knowledge of statistical analysis methods. Experience mentoring or coaching team members. Strong interpersonal and networking skills. Proficiency with computer systems and quality management applications.
Languages
- English
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