Quality Assurance Team Lead

Lonza•Tampa, FL

8d•Onsite

About The Position

The Quality Assurance Team Lead supports the organization’s initial compliance and ongoing preparation, testing, and monitoring of manufacturing quality assurance processes and standards. The role may focus on Manufacturing or Packaging and supports GMP operations through quality guidance, documentation review, quality activities, audits, and risk assessments. The position leads and develops QA Operations personnel and ensures activities comply with company SOPs, cGMP standards, and FDA regulations. This role is based in Tampa, Florida, and works a 12-hour rotating day shift.

Requirements

High school diploma required.
Experience in manufacturing operations, laboratory operations, and/or quality assurance.
One to two years of leadership experience.

Nice To Haves

Bachelor’s degree preferred.
Five years of experience with a bachelor’s degree.
Experience in pharmaceutical or biotech manufacturing, laboratory operations, or quality assurance preferred.

Responsibilities

Provide support and guidance to personnel on the GMP manufacturing and packaging floor, perform quality activities, and review documentation concurrent with GMP operations.
Review SOPs, batch records, test methods, and logbooks to ensure cGMP activities are completed and documented according to approved written procedures.
Review raw materials, work orders, validation reports, and MSAT reports as needed.
Independently write SOPs and related documentation.
Independently approve SOPs, Master Batch Records, customer audit CAPAs, and regulatory CAPAs.
Ensure QA activities comply with company SOPs, cGMP standards, and FDA regulations.
Disposition raw materials and/or finished products.
Assess the potential impact on product quality of open deviations during lot release.
Participate in investigations involving minor or major root causes, corrective or preventive actions, and potential impacts on product safety, identity, strength, quality, or purity.
Recommend changes to processes and programs.
Lead, train, develop, manage, and retain a team of QA Operations personnel.
Follow defined Safety and Sustainability requirements, seek clarification when requirements are unclear, report identified issues and opportunities to management, correct issues where possible, and stop work when needed to maintain safety.
Perform additional job-related assignments as requested by management or the QA Manager.