Quality Assurance Team Lead

Lonza Biologics, Inc.; Tampa (FL); Sur place; Confidential; Plein temps

Résumé du poste

Lonza Biologics, Inc. in Tampa, FL is seeking a Quality Assurance Lead to support GMP manufacturing and packaging operations on a 12-hour rotating day shift. The role focuses on QA activities, documentation review, and ensuring conformance to cGMP standards.

You will write and approve SOPs, Master Batch Records, CAPAs, and lead a QA Operations team while upholding FDA regulations and safety requirements.

Qualifications

• Bachelor’s degree preferred; high school diploma acceptable with relevant experience.
• 5+ years of experience in QA leadership.
• Experience in manufacturing operations or QA, preferably pharma/biotech.

Responsabilités

• Ensure QA Operations personnel engage on the GMP floor and provide support and guidance.
• Review SOPs, batch records, test methods, and logbooks for cGMP compliance.
• Write and approve SOPs, Master Batch Records, customer audits and CAPA.
• Lead, train, manage and retain QA Operations personnel.
• Adhere to Safety and Sustainability requirements and report issues to management.

Connaissances

QA Leadership

GMP knowledge

FDA regulations

Documentation review

Formation

Bachelor's degree

High school diploma

Description du poste

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.