Summary of Position

The Quality Assurance Specialist position reports directly to the Manager Quality Assurance. The Quality Assurance Specialist is responsible for implementing and supporting the Quality Management System (QMS) in accordance with Company policies and procedures.

Schedule : Monday - Friday 8am - 5pm

Essential Functions

• Write, revise, review, and approve site procedures and policies.
• Review and approve investigations and associated CAPAs.
• Participates in regulatory agency (i.e. FDA, etc.) inspections.
• Investigate or serve as GMP QA approver for customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented.
• Assemble, analyze and report QA data (metrics) to ensure regulatory compliance, identify trends and to identify areas of improvement.
• Review Batch Records and provide final product disposition.
• Conducts internal audits of GMP Quality Systems and sub systems.
• Aide in assessing risk during Vendor Qualifications or Material Assessments.
• Conducts incoming material disposition.
• Document Control, Training, Quality Systems back-up and key trainer.
• Reviews and assesses in-house solution preparation and external material testing.
• Conducts Vendor Qualification and reviews.
• Review and compile the Annual Product Quality Review.
• 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.

Requirements

• Bachelor Degree in Life Sciences or related field required.
• 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 regulations and guidelines and their application in a controlled aseptic environment is strongly preferred.
• Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.

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.

Competencies

Last updated : 2024-04-27