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QA Compliance Specialist at US02 Lonza Biologics Inc.

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Portsmouth, New Hampshire





Job Description:

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 

Do you want to help us as we shape the future of this great organization?

 

Job Description Summary

This is an advanced level Quality Assurance Specialist position that is responsible for planning and executing Internal Audits, and supporting preparation and execution of Pre Approval/Regulatory Inspections, customer audits, Global compliance audits at Lonza Portsmouth.

Primary Responsibilities:

Internal audits:


  • Act as Lead Auditor or Co-Auditor in the planning and performance of assigned internal audits. As part of audit planning, review recent trends and areas of concern, prepare audit checklists and the audit agenda.

  • As Lead Auditor, lead opening and closing meetings and communicate concerns to the departments in scope. Supervise auditors performing Lead Auditor tasks for training and qualification purposes.

  • Provide input to and/or write, issue, and disseminate the audit report. The Specialist can identify a compliance issue, and will have an understanding of GMP implications.

  • Review, follow up on, and approve audit responses. Escalate issues to supervisor when needed.

  • Initiate, track and close internal audit CAPA. The Specialist will work on complex CAPA records.

  • Author and/or contribute to the writing of the annual internal audit report and annual internal audit plan, as assigned.

  • Lead projects; define project plan, scope, and deliverables, as assigned.

  • Develop training materials for department and site personnel, as assigned.

  • Mentor and train other QA Specialists in all aspects of the role.  Assume supervisor role in absence of supervisor.

 

Customer audits, regulatory inspections, and Lonza Global compliance audits:


  • Act as Back Room Manager or Back Room staff.

  • Liaise with the site to fill front room requests from hosts. Disseminate information effectively.

  • Coach SMEs on the appropriate interaction with the front room.

  • Aid in the success of audits and inspections by appropriately triaging information to the site and effectively communicating with the front room.

  • Aid in the set-up and break down of the front room and back room.

  • Attend opening, closing, and lessons learned meetings to participate in continuous improvement.

  • Act as Front Room Host and Front Room staff, as assigned

  • Perform other duties as assigned.

Regular Office Hours.  A flexible schedule is expected to support audits and inspections and CAPA deadlines.

Quality Responsibility:

  • Adherence to cGMPs is required at all times during the manufacture of APIs.  All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. At the 4 level, the Specialist has an increased level of decision making, autonomy, level of authority and presentation skills.

Minimum Requirement Qualifications:


  • Education - 4 year BS Degree Preferred area of study:  Engineering, Regulatory, general science

  • Experience Advanced years in cGMP QA  (Intermediate to Advanced years in cGMP QA with ASQ certification)

  • Proven ability to communicate effectively, written and spoken

  • Licenses or Certifications - ASQ Certification preferred

  • Knowledge- Direct exposure to Regulatory Inspections, general inspection/audit expectations, in depth knowledge of company procedures and areas of concern. In depth knowledge of cGMP and current trends.

  • Skills - Written and verbal communication, ability to communicate QA and site expectations

  • Qualities & Attitude - Proactive attitude to keep current and reach out to networks and  to inform on best practices, Professional and competent rapport with the site, Quality focused and the ability to disseminate practical solutions, Ability to change focus as needed to support the immediate audit/inspection/deadline

 

 

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.

 

Lonza.  The place to Go, Stay and Grow.