(Contractor) Quality Assurance Specialist

Summary of Position

The (Contractor) Quality Assurance Specialist position is responsible for technical writing and document creation and is focused on ensuring the accuracy, integrity, and regulatory compliance of documents in a regulated environment. This position will generate and revise procedures, forms, etc., and support the quality assurance team as needed. This position reports to the Senior Director of Quality.
 

Work Schedule: 8am-4:30pm

Essential Functions

• Review and edit documents for accuracy, completeness, and consistency. 
• Track document status and manage document revisions and updates. 
• Perform QA on the Floor function.
• Gown into a grade C and D environment.
• Monitor aseptic operations for Quality Assurance.
• Review batch record completeness for accuracy and compliance.
• Manage and prioritize projects in an organized and structured manner.
• Create, review, and approve Quality policies and procedures.
• Initiate, review, approve and monitor Quality Events (Deviation, Change Control, CAPA, etc).
• Support regulatory and client audits.
• Conducts internal audits of the QMS and sub systems.
• Analyze data to identify areas for improvement in the quality system.
• Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

• Bachelor Degree in Science or related field required.  
• Minimum of three years of experience in a Pharmaceutical or Medical Device Quality Systems/Quality Assurance 
• Knowledge of tools, concepts and methodologies of Quality.
• Auditing experience, along with deviation and lot release support.
• Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of Computer Systems
• Working knowledge of cGMP guidelines.
• Proficient in use of Microsoft suite of products.

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