Quality Assurance (QA) Roles (Entry to Mid-Level) (Day-Shift)

Lonza • Portsmouth, NH

7d

About The Position

The Quality Assurance (QA) function is responsible for ensuring that all products, processes, and systems comply with internal standards, regulatory requirements, and industry best practices. QA professionals support quality and compliance activities across manufacturing, laboratory, and operational environments, with responsibilities that may include compliance oversight, deviation management, investigations, batch record review, on-the-floor quality support, and project or program management. At the entry level, QA professionals focus on executing routine quality tasks such as reviewing documentation, supporting Good Manufacturing Practice (GMP) compliance, assisting with investigations, and ensuring adherence to Standard Operating Procedures (SOPs). As experience grows, individuals take on increased ownership in deviation investigations, CAPA management, audit readiness, and cross-functional collaboration. Mid-level QA professionals are expected to lead complex investigations, manage quality systems, support regulatory inspections, and drive continuous improvement initiatives. They may also oversee quality-related projects or programs, partner with manufacturing and technical teams, and provide guidance to junior staff. Roles such as QA Project Manager and QA Program Manager involve coordinating cross-functional efforts, managing timelines, mitigating risks, and ensuring successful delivery of quality and compliance objectives. Across all levels, QA team members play a critical role in maintaining product quality, ensuring patient safety, and supporting regulatory compliance in a fast-paced, highly regulated environment.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related field (or equivalent experience)- A combination of education and years of experience will be considered.
• Strong attention to detail and organizational skills
• Basic understanding of GMP or regulated environments preferred
• Ability to follow SOPs and accurately document work
• Strong communication and willingness to learn
• 3–7+ years of experience in QA within a GMP-regulated industry
• Hands-on experience with deviations, investigations, CAPAs, and change controls
• Experience with batch record review and quality systems
• Familiarity with audits and regulatory inspections
• Experience with systems such as TrackWise, Veeva, LIMS, or similar
• Strong knowledge of GMP and quality systems
• Critical thinking and problem-solving skills
• Attention to detail and data integrity mindset
• Effective communication and cross-functional collaboration
• Ability to manage multiple priorities and meet deadlines
• Decision-making and risk assessment capabilities
• Project management skills (for mid-level and above roles)
• Continuous improvement mindset

Responsibilities

• Ensure compliance with GMP, regulatory requirements, and internal quality standards
• Review and approve batch records, protocols, reports, and quality documentation
• Support and/or lead deviation investigations, root cause analysis, and CAPA implementation
• Provide on-the-floor QA support to manufacturing and operations teams
• Participate in audits and inspections (internal, client, and regulatory)
• Monitor quality metrics and identify opportunities for continuous improvement
• Support change controls, risk assessments, and validation activities
• Collaborate cross-functionally with Manufacturing, QC, Regulatory, and Engineering teams
• Lead or support quality-related projects and programs, including timeline and risk management

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level