QA Specialist, DEA
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Summary
Experienced professional who assists and supports the organization to ensure compliance to Federal, state and local requirements for controlled substances (DEA). Responsible to implement, manage, and maintain Corporate DEA Compliance Program and collaborate to determine the overall DEA Compliance Strategy. Additionally, supports initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing. Alternatively, conducts internal production/process and manufacturing quality control audits and risk assessments. Role may be in Compliance, Lot Review or Audit/Inspection.
Key Accountabilities:
• Monitor all state and federal licensing requirements regarding the handling of controlled material
• Oversee the applications for procurement quota; Monitor the use of DEA 222 order forms for compliance with DEA requirements
• Responsibility for maintaining evolving Suspicious Order Monitoring Program and strategy while maintaining regulatory compliance and lead enhancement development
• Escalate and notify management and responsible agency in event of theft/diversion of controlled substances. Includes investigation into allegation of non-compliance or non-conformance reports
• Manage controlled substance inventory and monitor all associated activities to include periodic reporting (ARCOS and YERS reporting)
• Performs document reviews of SOP’s, batch records, test methods, and logbooks to ensure cGMP activities are completed and documented in accordance with approved, written procedures. May also review raw materials, work orders, validation and MSAT reports.
• Independently writes/approves SOPs, Master Batch Records, customer audit and regulatory CAPA as pertaining to controlled substance activity.
• Works with technical transfer teams to prepare new processes; act as responsible QA designee.
• May participate in investigations into minor and major root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity.
• Leads audits, and tracks audit and inspection commitments.
• Serve as liaison to the DEA.
• Creates and presents training seminars on compliance issues including DEA requirements for job role.
• Owns and leads special projects, often complex in nature.
• Ensure Compliance with DEA Import/Export Regulation
• Serve as Principle Consultant on the security design of all construction and renovation initiatives related, and not limited to all controlled substance manufacturing, packaging/labeling and storage.
• Ensure proper security controls are in place for shipping and receiving controlled drugs
• Coordination of controlled drugs destructions in accordance with DEA regulations
• Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
• Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
• Stop work where deemed necessary to maintain safety
Key Requirements:
Minimum Education Level Required: Bachelors
Preferred Field of Study: Science
Minimum Years Required Experience: 5
Preferred Field of Experience: Pharma cGMP
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 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.