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Jobs · Quality Assurance · New Hampshire

QA Operations Specialist IV - LSA (Nightshift)

Lonza · Portsmouth, NH · 2 wk ago
Quality AssuranceFull-time

About the role

This is a 3rd shift position operating on a 12-hour rotating schedule (7:00 PM – 7:00 AM). The schedule follows a rotating pattern of Monday–Tuesday workdays, Wednesday–Thursday off, Friday–Sunday workdays, and continues a biweekly rotation.

Responsibilities

  • Perform the daily rotation through GMP operational areas for the review of GMP documentation and observation of GMP work habits.
  • Provide direct coaching and feedback for GMP and documentation behaviors.
  • Conduct GMP training sessions as appropriate to support GMP work-habits and knowledge.
  • Provide GMP guidance to Manufacturing for routine and non-routine issues.
  • Able to independently deal with complex and novel issues.
  • Respond to QA Hotline calls in support of GMP operations.
  • Quality Assurance Specialist IV is responsible for decision-making, from simple to complex decisions.
  • Able to independently assess quality issues, make sound decisions, and appropriately escalate complex situations.
  • Authorize placement and removal of Quality Tag Outs.
  • Participate in Deviation lifecycle, including but not limited to, determination, review of minor deviations and approval of minor deviations.
  • Represent QA in meetings or on project teams, in audits, learning decision making as a QA representative conferring with senior staff and management.
  • Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
  • Perform other duties as assigned.

Requirements

  • Bachelor’s degree in life sciences discipline or equivalent experience.
  • 8+ years of experience in a cGMP-regulated pharmaceutical or biotechnology manufacturing environment.
  • Strong understanding of cGMP, ICH guidelines, and quality systems.
  • Working knowledge of manufacturing operations, including upstream/downstream processes, QC, or related functions.
  • Experience with quality systems and tools such as TrackWise, SAP, LIMS, Syncade, and Microsoft Office applications.
  • Ability to independently assess quality issues, make sound decisions, and appropriately escalate complex situations.
  • Strong communication and interpersonal skills, with the ability to provide clear guidance and influence GMP behaviors on the shop floor.
  • Experience in drug product manufacturing, QA operations, QC, or environmental monitoring within a GMP environment preferred.

Qualifications

Commensurate with experience.

Skills

  • Technical expertise in cGMP, ICH guidelines, and quality systems.
  • Strong problem-solving and decision-making skills.
  • Effective communication and interpersonal skills.
  • Experience with quality systems and tools such as TrackWise, SAP, LIMS, Syncade, and Microsoft Office applications.
  • Ability to independently assess quality issues and make sound decisions.

Benefits

Below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO).

Pay

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Schedule

This is a 3rd shift position operating on a 12-hour rotating schedule (7:00 PM – 7:00 AM). The schedule follows a rotating pattern of Monday–Tuesday workdays, Wednesday–Thursday off, Friday–Sunday workdays, and continues a biweekly rotation.

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