Quality Associate

Instant Systems•Norfolk, VA

About The Position

The Quality Associate will work in support of the Quality Department by performing a variety of activities to ensure compliance with applicable regulatory requirements and Instant Systems' quality procedures. The Quality Associate works to achieve department's goal and objectives.

Requirements

Associates degree in a relevant technical discipline or; a minimum of 3 years of relevant work experience in a GMP environment.
Keen attention to detail solid company-centric ideology.
creative problem-solving skills.
the ability to balance multiple priorities.
core values of honesty and respect.
a thirst for learning.
the desire to be challenged.

Nice To Haves

thrive in an autonomous work environment.
have a LEAN mindset.
are the first person to help.
seek out opportunities to bring added value.

Responsibilities

Assists in creating and maintaining documentation e.g. Procedures, Work Instructions, Quality Control Plans, calibration and maintenance logs, and retention sample programs.
Ensures production processes adhere to company policies, industry standards, and GMP (Good Manufacturing Practices) regulations.
Ensures conformance of Quality Systems to regulations and quality policies.
Ensures production documents are reviewed for accuracy and compliance to Instant Systems quality policies.
Updates, maintains and improves quality management systems process documents and documentation (physical & digital files).
Identifies quality risks in activities and processes according to regulatory agency guidelines and Instant Systems' quality policies and reports deviations from approved processes and procedures.
Supports during regulatory inspections, audits and Management Reviews.
Assists in coordinating corrective/preventive actions, continual improvement, customer complaints and non-conformances and investigating root cause and effectiveness of actions taken.
Tracks, reviews and assists in organizing reporting metrics and data for use in continuous improvement and Quality Management System reviews.
Drives continuous improvement of core processes to ensure the highest manufacturing standards and quality.
Other Responsibilities As assigned