Sr. Quality Associate
The Sr. Quality Associate is responsible for quality systems, compliance and Quality oversight of manufacturing operations and reports to Associate Director/Director Regulatory and Quality. Principle responsibilities are quality oversight of manufacturing activities at CMO, review of batch records, quality systems support, and compliance support.
Quality systems support may include, but is not limited to, ensuring the proper documentation, investigation, impact and risk assessments, corrective / preventive action plans, monitoring and trending. Support document control processes and systems for GxP activities in compliance with internal procedures and policies as well as regulatory requirements.
Essential Job Functions:
- Quality Support
- Manage the approval, distribution and archival of new and revised controlled documents.
- Control and execution of Deviations
- Corrective/Preventive Action (CAPA) plans
- Out-of-Specification/Out-of-Trend (OOS/OOT) results
- Nonconforming materials
- Environmental monitoring excursions
- Review and approval of stability studies
- Manufacturing Support may include, but is not limited to, the following:
- Oversight and Support of GMP Manufacturing Activities.
- Reviews production batch records and associated data for product release. Determines if records are within range of cGMP regulations. Reviews data obtained for compliance specifications and report abnormalities.
- Compliance support may include, but is not limited to, the following:
- Internal and external audits
- Preparation and support for internal audits
- Ability to problem solve, think critically and troubleshoot while working independently.
- Participate, observe, and/or monitor day to day quality operations.
- Ensure accurate and timely resolution of quality related activities.
- Communicate issues and assess their impacts and collaborate with others to resolve/mitigate those issues.
- Update management on activities as well as provide input and recommendations as appropriate.
Education, Experience, and Skills:
- A Bachelor's degree in science or engineering with minimum of five (5) years of Quality Assurance experience in a pharmaceutical / biotech industry is required.
- Must have strong critical thinking skills, initiative, integrity, and strong interpersonal and leadership skills. The ability to communicate clearly and precisely, both orally and in writing, is essential. Highly motivated, able to multi-task, strict attention to detail and open to be responsible for successful execution of tasks.
- The position requires extensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization is preferred.
- If you meet the requirements above and would like to apply for this position, please email your resume to firstname.lastname@example.org.