QA Specialist III-Operations OTF

Perform daily rotations through GMP operational areas, ensuring flawless review of GMP documentation and observation of work habits.

Provide outstanding mentorship and feedback on documentation behaviors, collaborating closely with Manufacturing Management.

Provide proven GMP mentorship on routine and non-routine issues, elevating sophisticated matters to senior staff and Management as needed.

Respond promptly to QA Hotline calls, effectively supporting GMP operations.

Independently make simple GMP decisions while collaborating with senior staff or management for sophisticated decision-making.

Authorize placement and removal of Quality Tag Outs, and release equipment from Product Changeover.

Apply Data Integrity principles in all aspects of work, ensuring compliance with Lonza's DI policies, guidelines, and procedures.

Represent QA in meetings or project teams, learning to successfully implement decisions as a QA representative in collaboration with senior staff.

Bachelor's Degree or equivalent experience required.

5-10 years of experience in a related field.

Outstanding attention to detail and a dedication to maintaining high standards of quality and compliance.

Ability to work independently and as part of a collaborative team.

Strong problem-solving skills and the ability to successfully implement solutions in a fast-paced environment.

Excellent communication skills, both written and verbal.

Confirmed experience in a GMP environment, with an extensive understanding of GMP principles and practices.