3rd Shift, QA Specialist

Job Overview

Under the general direction of the Director, Wilson Quality Operations, the Specialist is primarily responsible for supporting third‑shift Quality Assurance activities within the Rota Teq® POD facility at the Wilson, NC Site. This role is a core member of the Quality team in the Rota Teq® Integrated Process Team (IPT).

• Support commissioning, startup, licensure, and ongoing operations of the Rota Teq® POD facility.
• Oversee quality systems to meet business objectives while ensuring high standards for quality, safety, environmental, and EHS compliance.
• Promote continuous improvement aligned with MPS principles and foster an inclusive culture within the Quality team.
• Provide technical guidance to colleagues and receive guidance from the manager.

• Review, approve, and coordinate equipment/process validation and qualification activities.
• Develop and review SOPs, procedures, and document change control.
• Conduct audits, manage corrective actions, and support internal/external audit readiness.
• Perform finished product release activities per CBER release requirements.
• Manage defect resolution, investigate deviations, field alerts, and investigate and recommend disposition of affected material.
• Support environmental monitoring and regulatory document reviews.

• Maintain a culture of inclusion and positive employee relations.
• Participate in cross‑functional teams and advance project goals.
• Apply cGMP and safety knowledge to make performance‑driven decisions.
• Identify and correct problems to minimize adverse impacts.

• Drive improvement initiatives using lean six sigma and other methodologies.
• Collaborate across functions to implement efficiency and quality improvements.

• Ensure compliance with safety, environmental, cGMP, and labor regulations.
• Investigate root causes and implement CAPAs.
• Participate in internal and external audits, vendor inspections, and regulatory inspections.
• Track regulatory commitments and support new program implementation.

11:00 pm to 7:00 am, Monday through Friday (3rd‑shift night).

B.A./B.S. degree (preferably in Science or Engineering).

• Minimum 3 years of experience in pharmaceutical operations, technical services, or quality operations, with at least 1 year in a quality function.
• Strong leadership and communication skills.
• Capability to work independently within a team.
• Knowledge of cGMP and regulatory requirements in the vaccine/pharmaceutical industry.
• Proficiency with MS Office (Excel, Word, etc.).

• Experience with SAP/MES.
• Experience in aseptic filling and packaging.
• Experience with continuous improvement, lean manufacturing, and problem‑solving methodologies.
• Familiarity with change execution and coaching tools.
• Experience supporting regulatory inspections, including FDA.

Salary range: $87,300.00 – $. Additional annual bonus and long‑term incentive potential.

Comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick leave (see company benefits portal).

We are an equal opportunity employer. We do not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or other legally protected characteristics. For more information about your rights, visit EEOC resources.