Quality Assurance Team Lead

Lonza Group Ltd.; Tampa (FL); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Lonza Group Ltd. in Tampa, FL is seeking a Quality Assurance Lead to guide QA Operations on the GMP manufacturing and packaging floor.

The role includes reviewing SOPs, batch records, test methods, and logbooks, ensuring compliance with cGMP and FDA regulations. You will lead and develop a QA team, assess deviations, participate in investigations, and implement preventive actions, with a focus on product quality and safety in pharma/biotech contexts.

Competenze

• High school diploma or Bachelor's degree; 5+ years experience preferred.
• 1-2 years leadership experience.
• Experience in manufacturing operations, laboratory operations and/or QA, preferably pharma or biotech.

Mansioni

• Ensure QA Operations personnel engage on GMP floor, provide guidance and perform QA activities.
• Review SOPs, batch records, test methods and logbooks for cGMP compliance.
• Review raw materials, work orders, validation and MSAT reports as needed.
• Independently write SOPs or associated documentation.
• Independently approve SOPs, Master Batch Records, customer audits and CAPA.
• Ensure QA activities comply with SOPs, cGMP standards and FDA regulations.
• Dispositional authority for raw materials and finished products.
• Assess impact of deviations during lot release and investigations.
• Lead, train, develop, and retain QA Operations personnel.

Conoscenze

QA Leadership

GMP Compliance

SOP Review

Documentation Review

Team Training

Risk Assessments

Formazione

Bachelor's degree

Descrizione del lavoro

Quality Assurance Lead Tampa, FL Summary Experienced professional who assists and supports the organization with 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/packaging quality control audits and risk assessments. Role may be in Manufacturing or Packaging. Shift: 12 Hour Rotating Day Shift

What you will do:

• Ensures QA Operations personnel are actively engaging on the GMP manufacturing and packaging floor providing support and guidance to personnel, performing Quality activities, and executing documentation review concurrent with GMP Operations.
• Perform 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 write SOPs or associated documentation.
• Independently approve SOPs, Master Batch Records, customer audit and regulatory CAPA.
• Ensures that all QA activities are in compliance with company SOPs, cGMP standards and FDA regulations.
• Responsible of the disposition of raw materials and/or finished products.
• Assess potential impact to product quality for open deviations during lot release.
• Participate in investigations into minor major root cause, corrective or preventive actions and impact to product safety, identity, strength, quality, or purity.
• Make recommendations of changes to processes and programs.
• Lead, train, develops, manages and retains a team of QA Operations personnel.
• Perform additional job-related assignments as requested by management.
• 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.
• Other tasks as assigned by QA Manager.

What we are looking for:

High school diploma required or Bachelor’s degree, preferred Bachelors + 5 Years of Experience 1-2 Years Experience in Leadership Experience in manufacturing operations, laboratory operations and/or QA, preferably in pharma or biotech.

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.

Ready to shape the future of life sciences? Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong. You will feel at home at Lonza if you:

Take ownership, step forward, and enjoy meaningful responsibility Love solving problems and thrive in a complex, fast-moving environment Are curious, always looking to learn and improve Work collaboratively, contributing to something bigger than yourself Are motivated to make a difference through work that impacts customers and their patients Why Lonza: We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. We are the makers of the medicines of tomorrow. Join us. Be you.