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Senior Quality Assurance Operations Leader

Lonza - USA
locationKittery, ME 03904, USA
PublishedPublished: 6/14/2022
Technology
Full Time

Job Description

Job Description

Welcome to Lonza, a premier name in the life sciences industry globally. We believe there’s no secret recipe for our excellence—just highly skilled professionals collaborating to develop solutions that aid people and businesses alike. By joining our team, you’ll have the freedom to take charge of your career, contribute groundbreaking ideas, and make a genuine impact on the world. That’s the mission we invite you to be a part of.

In your role as a Senior QA Compliance Specialist 2- Operations at Lonza, you’ll be integral to New Hampshire’s thriving team. This position demands your expertise to uphold impeccable compliance and quality assurance within various GMP domains. As we expand with ambition, your role will ensure regulatory standards are maintained and pioneering processes executed successfully.

Shift Details: The ideal candidate will work Wednesday through Saturday from 9pm to 7:30am.

Responsibilities at a Glance:

  • Conduct daily rotations through GMP areas, reviewing documentation and observing practices.
  • Decide on the imposition or release of Quality Tag Outs.
  • Address QA Hotline inquiries to support GMP operations.
  • Mentor peers in Manufacturing, QC, Engineering/Facilities, and MSAT on GMP principles.
  • Document QAOTF shift notes and ensure follow-ups are conducted as necessary.
  • Serve as a QA representative in meetings and project discussions.
  • Pinpoint and recommend best practices to enhance QA processes.

Essentials to Thrive:

  • Exceptional communication skills, both in writing and speaking.
  • Keen attention to detail, along with commendable problem-solving and coordination skills.
  • Proven ability to collaborate effectively, even when delivering sensitive information.
  • Skilled at fostering positive relationships across departments, communicating clearly, and listening intently.
  • Experience with SAP, TrackWise, DMS, and LIMS is advantageous but not essential.
  • Adaptable to shifting tasks without sacrificing productivity.
  • Regular updates to project leads and teams about work progress.
  • Team-oriented mindset with a proactive approach to complete projects/tasks.
  • Proficient use of Microsoft Office tools.
  • Strong negotiation abilities to harmonize differing views.
  • Prioritize tasks effectively and manage time wisely.

Educational Background:

  • Bachelor’s Degree mandatory.
  • 3-5 years professional experience in a relevant field.

Every day at Lonza, our contributions reach millions, offering the dual honor and responsibility of ethical conduct and environmental stewardship. Our success rests on how we achieve these outcomes. Working at Lonza means engaging with rewarding challenges and crafting cutting-edge solutions in life sciences. Join us and feel the satisfaction of making profound contributions.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

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