The Principal Quality Assurance Engineer is responsible for the oversight and primary SME for quality assurance and validation for new products / projects. This position requires strong technical and training skills of quality systems. The position reports directly to the Senior Director of Site Quality. Knowledge in pharmaceutical quality systems with proficiency in quality oversight of a minimum of 50% of the following: Stability, Change Control, Internal Auditing, CAPA, Exceptions, Out of Specification Investigations, Customer Complaints, Document Control, Annual Product Reviews, Equipment Qualification and Process Validation.

• SME and Quality approver for GxP documentation associated with new products / projects through the project lifecycle.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Review and approve Change Control/Management Documents involving product or process changes.
• Key personnel for FDA or other regulatory agencies for on-site audits.
• Drive for resolution of product complaints, exceptions, corrective actions, OOS's, and/or safety issues.
• Assemble, analyze and report QA data to ensure regulatory compliance, identify trends and to identify areas of improvement.
• Conduct quality audits and develop and assess subsequent corrective action recommendation(s).
• Developing procedures, statistical evaluations, and remediation of systems.
• Ability to adapt quickly in a fast paced dynamic environment.
• Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
• Ensure a safe and quality working environment through training, awareness and compliance to safety guidelines and SOP's.
• Ensure the maintenance of the department, premises and equipment.
• Additional areas of responsibility may include developing sampling plans and standard operating procedures; providing quality training; actively participating in Material Review Board meetings; and assisting in preparation of regulatory submissions.
• Develop quality and validation project timelines and manage a sub team to ensure key milestones are accomplished.

• Bachelor of Science in Biology, Chemistry, Life Sciences or related field required.
• 8 or more years of relevant experience required.
• 3 or years of experience in supporting on-site inspections for regulatory agencies.
• Significant experience investigating exceptions and other variances.
• Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.
• Working knowledge of cGMP guidelines and their application in a controlled aseptic environment.
• Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
• Must have experience with statistical tools.
• Proficient in use of Microsoft suite of products.
• Experience developing and using project timelines, including MS Project, strongly preferred.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.