Quality Assurance Team Lead

Lonza•Tampa, FL

1d•Onsite

About The Position

The Quality Assurance Lead supports the organization with initial compliance and ongoing preparation, testing, and monitoring of conformance to established quality assurance processes and manufacturing standards. The role may focus on Manufacturing or Packaging and may also conduct internal production, process, manufacturing, or packaging quality-control audits and risk assessments. The position provides QA support and guidance on the GMP manufacturing and packaging floor, performs quality activities, and reviews documentation alongside GMP operations. It ensures compliance with company SOPs, cGMP standards, and FDA regulations; supports product disposition and investigations; and leads a team of QA Operations personnel. This role is based in Tampa, Florida, and works a 12-hour rotating day shift.

Requirements

High school diploma required.
Bachelor’s degree and five years of experience, preferred/stated as an experience qualification.
One to two years of leadership experience.
Experience in manufacturing operations, laboratory operations, and/or quality assurance.

Nice To Haves

Bachelor’s degree.
Experience in pharmaceutical or biotechnology manufacturing, laboratory operations, or quality assurance.

Responsibilities

Ensure QA Operations personnel actively support GMP manufacturing and packaging floor activities by providing guidance, performing quality activities, and reviewing documentation concurrent with GMP operations.
Review SOPs, batch records, test methods, and logbooks to ensure cGMP activities are completed and documented in accordance with approved written procedures.
Review raw materials, work orders, validation reports, and MSAT reports as needed.
Independently write SOPs and associated 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 potential product-quality impacts of open deviations during lot release.
Participate in investigations into minor and major issues, root causes, corrective and preventive actions, and impacts to 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.
Perform additional job-related assignments as requested by management and other tasks assigned by the QA Manager.
Adhere to defined Safety and Sustainability requirements and seek clarification when requirements are unknown or unclear.
Promptly report Safety and Sustainability issues, problems, deficiencies, errors, incidents, and opportunities to management, and correct them where possible.
Stop work when necessary to maintain safety.