Senior Quality Associate

7 days ago

Indianapolis, IN, United States Azenta Full time

Azenta Inc.

At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.

All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity

Job Title
Senior Quality Associate

Job Description

The Senior Quality Associate will provide direction and leadership to global personnel regarding operational compliance to all applicable federal and local guidelines. The Sr QA will create and implement policies and procedures which result in attaining quality goals and GxP globally.

What You'll Do

  • Comply with, enforce, and be held accountable for all GxP Practices and Quality Control Procedures (all members of the Quality Assurance team will be responsible for assuring compliance with 21 CFR, Part 11 or local equivalency on all systems not considered incidental).
  • Independently schedule and host client audits; respond to audit findings in a timely manner
  • Conduct internal audits for all Azenta Life Sciences facilities, including regional and client sites.
  • Routinely review and approve equipment validation documents such as temperature mapping, calibration, alarm validation, etc.
  • Compile the Management Review Meeting Presentation, including interpretation of data, charts, etc.
  • Process and review change requests for Global Operations.
  • Acts as system administrator for the Quality Management Software System.
  • Compile the department metrics utilizing reporting tools, including interpretation of data, creation of charts, etc.
What You Will Bring
  • Required
    • Four-year degree, preferred Life Sciences/Engineering.
    • 4 years' experience in Quality Assurance in a GxP facility or a combination of 2 years in Quality Assurance plus another 2 years' experience in a regulated industry.
    • Experience with regulatory audits and/or customer audits in a regulated environment.
    • Strong analytical skills and the ability to think creatively.
    • Strong verbal and written communication and interpersonal skills.
    • Demonstrated high level of initiative and ability to work independently.
  • Preferred
    • Experience with software/hardware validation.
    • Experience with supplier management
    • Training in GAMP or other ISPE validation courses.
    • Experience writing and managing SOP's and Quality Assurance and Business Policies.
Physical Requirements
  • Reaching, lifting, bending
  • Ability to lift 50 lbs.
  • Extended periods of standing or sitting
  • Right- and left-hand finger dexterity
  • Ability to discern colors or use of color correction glasses
  • Ability to work with refrigerants (e.g., dry ice and LNs) using proper PPE
Your Working Conditions:
  • Employee will be working in an area with potentially infectious materials.
  • Employee will be responsible for maintaining a clean work environment while enforcing and following universal precautions for blood borne pathogens when working in an area considered to be potentially contaminated.
  • Some travel, including international travel may be required.


EOE M/F/Disabled/VET

If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at Recruiting@azenta.com for assistance.

Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.

United States Base Compensation: $76,000.00 - $95,000.00

The posted pay range for this position is an estimate based on current market data and internal pay structure. Final compensation may vary above or below this range depending on factors such as experience, education (including licensure and certifications), qualifications, performance, and geographic location, among other relevant business or organizational needs.

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