Dedicated and results-driven Manufacturing Associate with hands-on experience in high-quality, GMP-regulated environments. Known for a strong work ethic, attention to detail, and commitment to operational excellence. Proven ability to follow complex procedures with accuracy while maintaining strict compliance with quality standards, safety protocols, and regulatory requirements. Skilled in supporting production processes, documenting batch records, and collaborating cross-functionally to ensure efficient and reliable manufacturing operations. Consistently recognized for reliability, accountability, and contributing to a culture of continuous improvement.
GMP Compliance & Documentation: Experienced in adhering to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) in a regulated biopharmaceutical environment Skilled in accurate batch record documentation, deviation reporting, and maintaining a compliant state
Aseptic Techniques & Cleanroom Practices: Proficient in working in ISO-classified cleanrooms under sterile and controlled environments, with a focus on contamination control and gowning procedures
Manufacturing Execution Systems (MES): Comfortable navigating and executing production instructions through electronic batch record systems and other digital manufacturing platforms
Quality-Focused Mindset: Committed to first-time-right execution and continuous improvement Actively contributes to process improvements, change controls, and root cause investigations
Training & Knowledge Transfer: Experienced in onboarding and mentoring peers on SOPs, equipment operations, and best practices in compliance-focused manufacturing environments