QA Compliance Specialist - LSA
Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 7:00 AM?4:00 PM EST.
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 will you do:
The QA Compliance Specialist supports the site\'s Quality Systems and Compliance programs by helping ensure adherence to GMP regulations, internal quality standards, and regulatory requirements. This role partners with Manufacturing, Quality Control, Validation, Engineering, and other functional teams to support quality events, quality systems activities, inspection readiness efforts, and continuous improvement initiatives.
Support Quality Systems activities including deviations, CAPAs, change controls, investigations, and quality risk management processes
Review quality records and documentation to ensure compliance with GMP requirements, site procedures, and regulatory expectations
Assist with inspection readiness activities, including preparation for regulatory inspections, customer audits, and internal audits
Support the tracking, trending, and reporting of Quality Metrics, KPIs, and compliance indicators
Collaborate with cross-functional teams to identify compliance gaps and support implementation of corrective and preventive actions
Provide GMP guidance and support to operational groups regarding quality systems and documentation requirements
Assist with the development, revision, and management of SOPs and other quality-related documentation
Support site quality initiatives, continuous improvement projects, training activities, and other compliance-related responsibilities as assigned
What we are looking for:
Bachelor\'s degree in Life Sciences, Chemistry, Biology, Engineering, or a related scientific discipline preferred
Minimum of 3+ years of experience in Quality Assurance, Compliance, Quality Systems, or a related role within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment
Working knowledge of cGMP regulations, FDA requirements, and applicable ICH guidelines
Experience supporting deviations, CAPAs, change controls, investigations, and quality system processes
Familiarity with regulatory inspections, customer audits, and inspection readiness activities
Strong analytical, organizational, and problem-solving skills with attention to detail and compliance
Ability to multitask and prioritize work in a dynamic, fast-paced, green-field environment
Excellent written and verbal communication skills with the ability to effectively collaborate across departments
Experience with electronic Quality Management Systems (eQMS) such as TrackWise, Veeva, MasterControl, or similar platforms preferred
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.
Ready to shape the future of life sciences? Apply now.
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