Division

About the Organization
By joining the Instant Systems team, you will be at the forefront of innovation in med tech and biotechnology. You will work with innovative companies who are leading the way in creating lifesaving therapies for patients around the world. You will work side by side with your fellow team members to create future innovations for best patient outcomes. We are looking for strategic problem solvers who thrive in an autonomous environment of diverse and energized collaborators. If you are motivated by new challenges and opportunities for skills growth, we welcome you to apply. Your energy and expertise is valuable, spend it making a difference on a worthy mission.

Description

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.

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

To be considered you'll need:

• 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.

You will thrive if you:

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

Company Benefits & Perks

• 401K
• Health Benefits: Medical, Dental, Vision
• Wellness Program
• Life Insurance
• Corporate Sponsored Events
• Skill growth opportunities
• Short Term Disability
• Ability to Advance
• Working with energetic & creative problem solvers
• A mission worthy of your energy and expertise

Applicants for this position must successfully pass a background and drug screening. It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

Full-Time/Part-Time
Full-Time

EOE Statement
Instant Systems' provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Salary Range

This position is currently accepting applications.