On-the-Floor GMP QA Lead (Night Shift)

Lonza Biologics, Inc.; Portsmouth (VA); On-site; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability

Employee assistance programs

Paid time off

Job summary

Lonza Biologics, Inc. is seeking a QA Specialist II – Operations to provide on-the-floor QA support in GMP environments at the Portsmouth, NH site.

The role operates on a 12-hour rotating schedule with third shift coverage, collaborating with GMP operators and manufacturing teams to ensure compliant documentation and data integrity. The successful candidate will guide GMP behaviors, assist with routine and non-routine compliance questions, and support inspection readiness while maintaining

Qualifications

• Associate or bachelor's degree in a scientific or engineering discipline preferred; equivalent relevant experience may be considered.
• Basic understanding of cGMP regulations and good documentation practices.
• Familiarity with manufacturing process steps and quality control activities within a regulated environment.
• Awareness of product clearance and line clearance requirements during manufacturing operations.
• Experience following SOPs and completing required documentation accurately.
• Familiarity with manufacturing and quality systems such as SAP, LIMS, TrackWise, Syncade, or similar systems preferred.
• Ability to recognize potential compliance issues and communicate concerns to supervisors or appropriate team members.
• Strong attention to detail and the ability to identify unusual events or conditions and escalated appropriately.
• Effective communication and organizational skills with the ability to work collaboratively in a team environment.

Responsibilities

• Conduct daily QA presence in GMP operational areas to review documentation and observe GMP practices.
• Partner with Manufacturing and Operations teams to ensure compliance with GMP standards and internal procedures.
• Provide guidance and coaching on GMP behaviors and documentation practices in collaboration with Manufacturing leadership.
• Support Manufacturing teams with both routine and non-routine GMP compliance questions or issues.
• Escalate complex compliance issues or risks to senior QA staff or management when appropriate.
• Respond to QA Hotline calls and provide support for operational GMP-related questions or events.
• Independently make routine GMP-related decisions and collaborate with senior staff or management on more complex decisions.
• Support equipment status management, including authorizing placement or removal of Quality Tag Outs and releasing equipment from product changeover.
• Apply Data Integrity (DI) principles in all aspects of work in accordance with company policies, guidelines, and procedures.
• Represent Quality Assurance in meetings and cross-functional project teams, contributing to compliance-focused decision making.
• Support the facility’s state of inspection readiness through proactive QA oversight and engagement.
• Perform additional duties as assigned.

Skills

GMP

Data Integrity

SOPs

Documentation

SAP

LIMS

TrackWise

Syncade

QA

Education

Associate or Bachelor's degree in a scientific or engineering discipline

Tools

SAP

LIMS

TrackWise

Syncade

Job description

Lonza Biologics, Inc. is seeking a QA Specialist II – Operations to provide on-the-floor QA support in GMP environments at the Portsmouth, NH site.

The role operates on a 12-hour rotating schedule with third shift coverage, collaborating with GMP operators and manufacturing teams to ensure compliant documentation and data integrity. The successful candidate will guide GMP behaviors, assist with routine and non-routine compliance questions, and support inspection readiness while maintaining