QA Specialist II - Operations

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

QA Specialist II – Operations

Location: This position is based in our Portsmouth, NH office. 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 on a biweekly rotation.

What you will get:

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).

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

What you will do:

The QA Specialist III operates with a high degree of autonomy while partnering closely with GMP operators and manufacturing teams to provide real-time, on-the-floor Quality Assurance support for operational areas involved in GMP activities. This role is responsible for supporting compliance within manufacturing operations by ensuring adherence to GMP standards, data integrity principles, and internal quality procedures.

As an experienced member of the QA team, the QA Specialist III handles complex and time-sensitive assignments, supports inspection readiness, and may provide guidance or coaching to less experienced staff. The position serves as a key Quality representative within operational areas, helping to maintain compliant processes, documentation practices, and overall operational excellence.

• 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.

What we are looking for:

• Associate or bachelor's degree in a scientific or engineering discipline (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, or related field) 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 standard operating procedures (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.

• Ability to prioritize routine tasks and work effectively under general supervision.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.