Supervisor Quality Assurance Jobs

Job Summary

We are seeking a Supervisor Quality Assurance, Regulatory Affairs & Compliance for our Biologics Testing Solutions site located in Wayne, PA.

Supervise and provide support in the management of daily workflow operation of the Quality Assurance (QA) Client Audit Group staff. Ensure staff assignments are in alignment with the regulatory inspection and reporting requirements.

The following are responsibilities related to the Supervisor Quality Assurance, Regulatory Affairs & Compliance.

• Oversee daily operation activities and schedule to ensure QA resources are properly assigned to manage regulatory oversight.
• Demonstrate extensive knowledge and understanding of Quality Management System (QMS).
• Ensure adherence to pertinent regulatory requirements and to department policies, practices and procedures.
• Host Client audits and participate in regulatory inspections.

Minimum Qualifications

The following are minimum requirements related to the Supervisor Quality Assurance, Regulatory Affairs & Compliance position.

• Other: Knowledge of Microsoft Office applications. Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Excellent judgment, decision-making, training, mentoring skills, and verbal written communication skills. Must have strong leadership and organizational skills. Must work well on a team and be detail oriented. Must be able to prioritize workload and manage multiple tasks.
• Certification/Licensure: None
• Education: Bachelor’s Degree (B.A/B.S) or equivalent, preferably in life science or related discipline.
• Experience: Minimum 5 years’ experience in Quality Assurance role or GLM/GMP environment including minimum of 1-year supervisory experience.