Quality Assurance Specialist

JOB SUMMARY: Ensures that services adhere to the company’s quality standards. Responsible for developing quality inspection procedures and implementing inspection activities that detect and resolve product or service defects. The QA Specialist must have a general understanding of quality systems including; documentation control, training, deviations, CAPA, complaints, validation, audits, change control, calibrations and supplier management. The QA Specialist is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes and controls.

DUTIES AND RESPONSILITIES:

• Oversee the generation, review, approval, and archival of controlled documents used to support GxP operations. Ensure consistency and compliance to formatting and template requirements.
• Writing and revising standard operating procedures (SOPs).
• Maintain controlled documentation archive.
• Ensure systems are in compliance with current SOPs and pharmaceutical industry and hazardous waste laws & regulations.
• Participation in QA operational activities, including: change controls, non-conformance/deviation investigations, complaints, CAPA, CAPA effectiveness check, validation of equipment & software, internal and external audits, & approving GxP operations suppliers.
• Participation in Lean process improvement projects.
• Perform internal audits of procedures and processes as assigned.
• Maintain inspection readiness and participate in external and regulatory audits.
• Perform review and approval of deviations and nonconformance as required.
• Assist investigations and resolve potential service & product quality issues to improve efficiency.
• Implement, monitor, and record all corrective and preventive actions taken.
• Perform, review, approve, and record risk management assessments for deviations, validation, supplier management and other processes as required.
• Review and approve validation plans and protocols (IQ/OQ/PQ) for GxP computer systems and equipment.
• Support the establishment and periodic review of the Quality Management System (QMS).
• Manage quality projects as requested by Management and role.
• Maintain schedules and coordinate activities for project efforts.
• Evaluate procedures and coordinate with subject matter experts to identify areas of quality and process improvement.
• Develop and maintain positive relationships with other departments and management.
• May perform additional duties as required.

JOB REQUIREMENTS / QUALIFICATIONS:

• Excellent verbal and written communication skills.
• Excellent organizational and analytical skills and attention to detail.
• Ability to take complex, technical information and translate it for colleagues and consumers who have nontechnical backgrounds.
• Ability to meet deadlines and to work independently.
• Ability to work as part of a team.
• Decision-making skills.
• Proficient with Microsoft Office Suite or related software.

PHYSICAL REQUIREMENTS:

• Prolonged periods sitting at a desk and working on a computer.

DESIRED KNOWLEDGE / SKILLS:

• Bachelor’s, or higher, degree in a scientific discipline preferred.
• 2 years of experience in a GxP environment.
• Lean Six Sigma green belt or higher.
• Preferred: In-depth understanding of industry standards and regulations.

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