Sr. Quality Associate

7 days ago

Plainfield, United States Virtual Company Full time

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. 

Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally.   We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.

How You’ll Add Value

The Senior Quality Associate will create and implement policies and procedures which result in attaining quality goals and GxP globally. The Senior Quality Associate will provide direction and leadership to global personnel regarding operational compliance to all applicable federal and local guidelines. They will be expected to comply with, enforce, and be held accountable for all GxP Practices and Quality Control Procedures. All members of the 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.

What You’ll Do

  • Responsible for internally auditing and reviewing the company validation program including but not limited to Master Validation Plan, Change Controls, and Periodic Validation reviews.
  • Routinely reviews and approves company validation documents such as software validations, hardware validations, calibrations, alarm validations, etc.
  • Reviews relevant software systems for compliance with 21CFR part 11
  • Assists in the scheduling, facilitating and responds to client and regulatory audits or visits.
  • Conducts internal audits for all US sites and On-sites.
  • Conducts supplier audits and manages supplier qualification
  • Compiles the Management Review Meeting Presentation, including interpretation of data, charts, etc.
  • Processes and reviews change control requests for Global Operations.
  • Acts as system owner/administrator for Qualtrax®.
  • Compiles 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.
  • 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.
  •  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.
  • Proficiency in Microsoft Office Products.
  • Proficiency in Analytical Software.
  • Experience with internal auditing.

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

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