The Specialist QA supports and ensures compliance with quality systems and regulatory requirements in a regulated manufacturing environment. This role is responsible for reviewing and approving quality and manufacturing documentation, supporting investigations, managing quality events, and participating in validation, change control, and new product introduction activities. The specialist works cross-functionally to ensure manufacturing operations meet established quality standards and regulatory expectations.

Key Responsibilities

• Review and approve manufacturing procedures, master production records, and related documentation.
• Review and approve process validation protocols, reports, and qualification documentation.
• Review and approve environmental monitoring and environmental characterization reports.
• Provide quality oversight for sanitary utility systems and support system release activities.
• Review and approve work orders, alarms, and system notifications impacting product quality.
• Support automation, facilities, and environmental compliance programs.
• Review, approve, and manage non-conformance investigations and CAPA records.
• Review and approve change controls and assess potential product quality impact.
• Review and approve risk assessments related to manufacturing processes and systems.
• Participate in incident triage activities and support timely resolution of quality events.
• Own and maintain site quality procedures and ensure alignment with regulatory and internal requirements.
• Perform lot disposition activities and authorize product release in accordance with quality standards.
• Ensure all product release documentation is complete, accurate, and compliant.
• Lead quality investigations, including root cause analysis and corrective actions.
• Lead and participate in internal audits and support external regulatory inspections.
• Identify trends and support implementation of corrective and preventive actions.
• Support continuous improvement initiatives to strengthen quality systems.
• Represent Quality Assurance on cross-functional teams, including New Product Introduction (NPI) initiatives.
• Support implementation of process, equipment, and system changes.
• Participate in change control review boards and provide quality guidance.
• Collaborate with Manufacturing, Engineering, Validation, and other technical teams to ensure compliance.
• Support validation activities, including process performance qualification (PPQ) and equipment qualification.

Requirements

Education and Experience

• Doctorate degree in Science, Engineering, or related field, OR
• Master’s degree with 2 years of directly related experience, OR
• Bachelor’s degree in Science, Engineering, or related field with 4 years of directly related experience, OR
• Associate’s degree with 8 years of directly related experience, OR
• High school diploma / GED with 10 years of directly related experience

Preferred Field of Study:

• Biology
• Microbiology
• Chemistry
• Engineering
• Pharmaceutical Sciences or related discipline

Preferred Qualifications

• Experience supporting New Product Introduction (NPI) activities.
• Experience with change control, validation, and documentation review.
• Experience supporting process validation and Process Performance Qualification (PPQ).
• Experience supporting factory acceptance testing (FAT) and equipment qualification.
• Experience working in pharmaceutical, biotechnology, or regulated manufacturing environments.

Required Skills and Competencies

• Strong knowledge of GMP regulations and quality systems.
• Experience supporting manufacturing, validation, and quality operations in regulated environments.
• Understanding of change control, CAPA, deviation management, and risk management processes.
• Experience supporting validation activities, including PPQ and equipment qualification.
• Experience with quality documentation review and approval.
• Strong organizational and project management skills.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Experience with quality management systems, change control systems, and documentation systems is preferred.

Benefits

• Administrative shift
• Contract position