Quality Associate

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.

• Assists in creating and maintaining documentation (Procedures, Work Instructions, QC Plans, calibration and maintenance logs, and retention sample programs).
• Ensures production processes adhere to company policies, industry standards, and GMP 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.

• As assigned

• Associate degree in a relevant technical discipline.
• 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.

• Thrives in an autonomous work environment.
• Has a LEAN mindset.
• Is the first person to help.
• Seeks out opportunities to bring added value.

• 401(k)
• 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.