QA Operations Specialist II/III

We are seeking a detail-oriented and experienced QA Operations Specialist at the II or III level to join a dynamic Quality team within a regulated pharmaceutical or biotechnology environment. In this role, you will be an integral part of day-to-day quality operations, supporting manufacturing, documentation, and deviation management activities in alignment with GMP standards and regulatory requirements. This is an excellent opportunity for a quality professional looking to deepen their expertise and grow within a collaborative, science-driven organization.KEY RESPONSIBILITIES

• Perform line-clearance and change-over activities to support manufacturing operations.
• Manage disposition, hold, and rejection of raw materials, starting materials, and in-house prepared materials in accordance with GMP requirements.
• Generate and reconcile in-process and Drug Product labels with accuracy and compliance.
• Review and approve executed documents related to manufacturing operations, QC, and other departments.
• Initiate and author deviations, CAPAs, and Change Controls associated with Quality Operations practices.
• Create, review, and approve procedures and practices within Quality Operations to implement and maintain quality standards.
• Partner cross-functionally with other departments to implement and optimize batch records, practices, and procedures.
• Perform other duties as assigned in support of the Quality Operations function.

QUALIFICATIONS

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related discipline required.
• 2 or more years of experience in Quality Assurance or a GMP-regulated role within the pharmaceutical, biotechnology, or related industry (Level II); 4 or more years of progressive QA experience preferred for Level III consideration.
• Hands-on experience with deviation management, CAPA authoring, and Change Control processes.
• Working knowledge of batch record review, label reconciliation, and document control practices.
• Solid understanding of GMP principles and familiarity with Health Authority regulations such as US FDA, ISO 9001, and ISO 13485.
• Familiarity with line-clearance, material disposition, and in-process quality oversight in a manufacturing environment.
• Strong verbal and written communication skills, with the ability to clearly document quality events and collaborate across departments.
• Excellent attention to detail, organizational skills, and the ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Strong analytical and problem-solving capabilities with a root cause-oriented mindset.
• Proficiency with Microsoft Office Suite or related software.