Quality Operation Specialist

The Quality Operations Specialist plays a critical role in overseeing the quality system within manufacturing and production areas. This includes monitoring, documenting, and addressing quality-related issues to ensure compliance with company standards and regulatory requirements. The role involves collaborating with various teams to uphold the highest quality standards for released batches. Key Responsibilities: Ensure manufactured products adhere to company policies, processes, and procedures. Provide quality oversight for GMP manufacturing, including technical operations, engineering, QC labs, and supply chain activities. Review and approve incoming material inspections, batch records, manufacturing logs, and line-clearance activities. Manage the release of materials and product batches. Investigate non-compliance issues in materials, QC testing, manufacturing, warehousing, and products. Support change management processes to ensure compliance with policies. Conduct routine inspections of manufacturing, engineering, warehouse, and QC areas to maintain compliance. Contribute to new product introductions, operational excellence initiatives, and other management-assigned tasks. ABOUT YOU Bachelor’s degree in Natural Sciences (Biology, Chemistry), Pharmacy, or Engineering. 2+ years of experience in a pharmaceutical or biopharmaceutical quality/compliance environment (GxP). Familiarity with quality regulations and standards affecting APIs/Biologics. Experience with SAP and Trackwise is a plus. Strong knowledge of GxP requirements and regulatory standards. Ability to quickly understand products and processes to address quality issues effectively. Commitment to maintaining high-quality standards with integrity and a strong work ethic. Excellent planning, scheduling, and communication skills. Strong interpersonal skills for effective collaboration. WHAT WE OFFER An international community bringing together diverse perspectives and expertise. Opportunities for continuous professional development through our robust training programs. A vibrant workplace with frequent internal events fostering collaboration and innovation. Commitment to Corporate Social Responsibility through our sustainability initiatives. Equal Opportunity Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics. #J-18808-Ljbffr