QA Specialist, Operations - 12hr Day or Night Shift

Lonza•Tampa, FL

8d•Onsite

About The Position

The QA Specialist, Operations supports manufacturing quality assurance in Lonza’s Tampa, Florida location. The role helps ensure compliance with cGMP standards and contributes to product quality and safety through document review and approval, product quality assessments, investigations, audits, and collaboration across departments. The position is listed as a 12-hour shift, with day or night shift options; the posting also identifies the role as a 3rd shift position. The specialist collaborates with cross-functional teams, attends client meetings and calls, and supports regulatory inspections and quality initiatives. The role also requires adherence to safety and sustainability requirements, including promptly reporting and correcting issues.

Requirements

Bachelor’s degree in a Science or related field, or equivalent experience.
Proficient experience in quality assurance or manufacturing.
Knowledge of Pharma cGMP standards.
Familiarity with Quality Management Systems such as Trackwise and SAP, and with Microsoft Office tools.
Strong attention to detail.
Ability to work collaboratively across teams.

Nice To Haves

Experience in audits and regulatory compliance processes is advantageous.

Responsibilities

Review SOPs, batch records, test methods, protocols, deviations, CAPA, and related documentation for compliance with cGMP standards.
Approve SOPs, Master Batch Records, executed batch records, and laboratory data reports.
Assess product quality impact for open deviations during lot release.
Participate in investigations and internal, vendor, and customer audits.
Provide support during regulatory inspections.
Collaborate with cross-functional teams to resolve issues and achieve departmental goals.
Attend client meetings and calls to support quality initiatives.
Ensure adherence to safety and sustainability requirements, reporting and correcting issues promptly.