QA Specialist II - Operations

What you will do

The QA Specialist operates with a high degree of autonomy while partnering closely with GMP operators and manufacturing teams to provide real-time, on-the-floor Quality Assurance support for operational areas involved in GMP activities. This role is responsible for supporting compliance within manufacturing operations by ensuring adherence to GMP standards, data integrity principles, and internal quality procedures.

As an experienced member of the QA team, the QA Specialist handles complex and time-sensitive assignments, supports inspection readiness, and may provide guidance or coaching to less experienced staff. The position serves as a key Quality representative within operational areas, helping to maintain compliant processes, documentation practices, and overall operational excellence.

• Conduct daily QA presence in GMP operational areas to review documentation and observe GMP practices.
• Partner with Manufacturing and Operations teams to ensure compliance with GMP standards and internal procedures.
• Provide guidance and coaching on GMP behaviors and documentation practices in collaboration with Manufacturing leadership.
• Support Manufacturing teams with both routine and non-routine GMP compliance questions or issues.
• Escalate complex compliance issues or risks to senior QA staff or management when appropriate.
• Respond to QA Hotline calls and provide support for operational GMP-related questions or events.
• Independently make routine GMP-related decisions and collaborate with senior staff or management on more complex decisions.
• Support equipment status management, including authorizing placement or removal of Quality Tag Outs and releasing equipment from product changeover.
• Apply Data Integrity (DI) principles in all aspects of work in accordance with company policies, guidelines, and procedures.
• Represent Quality Assurance in meetings and cross-functional project teams, contributing to compliance-focused decision making.
• Support the facility's state of inspection readiness through proactive QA oversight and engagement.
• Perform additional duties as assigned.

What we are looking for

• Associate or bachelor's degree in a scientific or engineering discipline (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, or related field) preferred; equivalent relevant experience may be considered.
• Basic understanding of cGMP regulations and good documentation practices.
• Familiarity with manufacturing process steps and quality control activities within a regulated environment.
• Awareness of product clearance and line clearance requirements during manufacturing operations.
• Experience following standard operating procedures (SOPs) and completing required documentation accurately.
• Familiarity with manufacturing and quality systems such as SAP, LIMS, TrackWise, Syncade, or similar systems preferred.
• Ability to recognize potential compliance issues and communicate concerns to supervisors or appropriate team members.
• Strong attention to detail and the ability to identify unusual events or conditions and escalate appropriately.
• Effective communication and organizational skills with the ability to work collaboratively in a team environment.
• Ability to prioritize routine tasks and work effectively under general supervision.