Work Flexibility: Remote
What you will do
In this role, you will act as the key Quality Assurance partner for Finished Goods Operations (FGO), supporting lot review, product release, and quality processes to ensure compliance with regulatory requirements. You will work closely with cross-functional teams, including Microbiology and Operations, to maintain consistency in acceptance and inspection activities in a highly regulated environment.
Main responsabilities:
- Perform lot review and product release activities for Finished Goods, ensuring compliance with internal procedures and regulatory requirements.
- Review and approve quality documentation related to Finished Goods acceptance, inspection, and release processes.
- Coordinate with cross-functional teams (Operations, Microbiology, Regulatory) to ensure consistent execution of Finished Goods quality processes.
- Support nonconformance investigations and CAPA activities related to Finished Goods acceptance and inspection activities.
- Provide Quality Assurance support to resolve internal, customer, and supplier-related issues impacting Finished Goods compliance.
- Monitor and support quality metrics related to Finished Goods, including nonconformances, CAPA, product holds, and process changes.
- Support internal and external audits (e.g., FDA and other regulatory bodies) related to Finished Goods Operations.
- Drive continuous improvement initiatives to enhance Finished Goods acceptance, inspection, and release processes.
What you need
Required:
- Bachelor’s degree in Engineering.
- Minimum 2 years of experience as Quality Engineer within highly regulated environments (e.g., medical devices, pharmaceuticals, automotive, aerospace).
- Experience reviewing documentation and supporting quality or operational processes.
- Knowledge of regulated environments and quality systems (e.g., GMP or equivalent).
- Fluent English proficiency (written and verbal).
- Proficiency in Microsoft Office (Excel, Word, PowerPoint).
Preferred:
- Experience with lot review, product release, or quality documentation processes.
- Familiarity with ERP systems such as SAP, Oracle, or similar.
- Experience supporting audits or quality system activities.
Travel Percentage: 10%