Quality Assurance Associate III - United States
The Quality Assurance Associate III (contract) is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations and established procedures. They support the review and management of product technical complaints and change control, manage the EMG-NA Quality Management System including revision of SOPs, review annual product reviews, review of batch records, maintain and utilize Quality Assurance databases, review documentation for compliance with cGMPs, FDA, ICH and other regulatory requirements and perform administrative tasks.
The Quality Assurance Associate III (contract) position will be part of the EMG - NA team that has primary responsibility for providing Quality oversight for 3rd Party Manufacturing (Contract Manufacturing Operations) to oversee activities of QA/QC and compliance functions to ensure compliance with current Good Manufacturing Practices (cGMPs). The individual will work closely with the EMG-NA Quality Unit, stakeholders and CMOs to ensure compliance and continuous improvement in quality functions. In addition, the individual will support the systems that ensure the Quality and Regulatory Compliance of products sub-contracted to external entities on behalf of the client in accordance with cGMPs and client Quality directives
- Duties include but are not limited to:
- Support the continued develop of the EM NA Quality Management System
- Support the management of complaints, deviations, change controls, non-conformities etc.
- Support the External Manufacturing North America Audit Program
- Support the development and negotiation of Quality Agreements
- Compile and report KPIs.
- Review CMO validation protocols, Master Documents etc.
- Support routine meetings with CMOs.
- Other duties as defined by Head of EMG-NA Quality
- Knowledge / understanding of cGMP regulations, requirements and expectation
- Knowledge /understanding of pharmaceutical Quality operations
- Knowledge / understanding of pharmaceutical manufacturing
- Excellent team work
- Willingness / commitment to learning
- Minimum BA/BS from an accredited school in a science, engineering or health field (e.g,, Chemistry, Pharmacy, Biology, Chemical Engineering)
- 6 – 9 years' experience within a pharmaceutical Quality Assurance department
- Experience with electronic Quality databases/systems, e.g., Trackwise, SAP