QA Compliance Specialist
United States, Portsmouth (New Hampshire)
The QA Compliance Specialist is responsible for performing quality processes in accordance with written procedures including temporary and permanent change control management, deviations, stand-alone investigations and CAPAs (Corrective and Preventative Actions). The QA (Quality Assurance) Compliance Specialist will review and approve the quality records to assure they are complete and that there is sound justification/scientific rationale. The QA Compliance Specialist will require little direction for day to day activities or escalation of issues; they will identify and implement quality system process improvements and mentor less experienced QA Compliance Specialists.
Level of role (I, II, III) based on experience and qualifications
- Review and approve documents such as SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications, Forms & Checklists, Scanned Documents and others as needed. Specialist will also review and approve electronic and/or paper Validation / Qualification documents such as Protocols & Summary Reports for CIP, SIP Equipment/Instrumentation, Validation Maintenance, Computer Systems & Stability.
- Reviews and adjusts Key Performance Indicator quality metrics
- Prepares various product specific documents as needed such as Product Quality Reviews etc.
- Identifies opportunities for improvement, defines the project plan, scope, and deliverables
- Represents department at site meetings as needed
- Supports audits and Regulatory inspections as needed
- Bachelor’s Degree or equivalent experience. Preferred area of study: Scientific related field
- Substantial experience in GMP (Good Manufacturing Practices) environment.
- Biotechnology manufacturing background is preferred.
- Significant experience in Quality Assurance or similar discipline, within biologics, biotechnology, pharmaceutical or clinical environment.
- Project Management Skills, including Presentations, Customer Liaison, Meeting facilitation
- Experience with Trackwise, SAP, Syncade and Microsoft Suite preferred
- Demonstrates quality decision making
- Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities, attention to detail, works effectively individually and with teams, positive attitude, customer focused, works well under pressure, confident making quality decisions, able to motivate others.
- Practices safety awareness at all times and considers impact of actions prior to executing activities.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if it is not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.