Quality Assurance Specialist

Description

The quality team protects patients by making sure every product delivered is safe and effective.

The work spans development, maintenance, compliance and research analysis, and it has a direct effect on patient care.

The team keeps a quality culture that adapts to patient needs and is grounded in science and risk-based compliance.

Responsibilities

• Review clinical and commercial drug batches to confirm they meet quality standards.
• Check product and process documents against specifications using careful sampling and statistical process control.
• Spot deviations from manufacturing and packaging standards and take steps to correct them.
• Sign off on investigations and oversee change control to keep configuration management policies followed.
• Take on project tasks and milestones, planning your work to hit deadlines.
• Build basic team effectiveness skills within your immediate team.
• Choose among a small set of options to solve routine problems, working under your supervisor's direction.
• Confirm manufacturing and packaging records follow company policy and cGMP.
• Keep the site ready for inspections, support regulatory and customer audits, and help improve quality assurance systems.
• Help manufacturing and packaging staff catch and fix compliance errors as they happen, and lead or join Quality Risk Management assessments.

Requirements

• A bachelor's degree of any discipline, or an associate's degree with 4 years of relevant experience, or a high school diploma or equivalent with 6 years of relevant experience.
• Experience in the pharmaceutical industry and with quality management systems.
• Solid working knowledge of cGMP, which sits within GxP.
• Ability to work well within your own team and across departments.
• Clear written and spoken communication.
• Must not be allergic to penicillin, since this is a penicillin manufacturing facility.
• Preferred: experience at a manufacturing site.
• Preferred: experience writing and managing deviations.
• Preferred: experience with production batch record review, ERP systems, non-conformance investigation, root cause analysis and change control.
• Preferred: strong problem-solving skills.
• Preferred: ability to work on your own as well as in a team.
• Preferred: strong time management and the ability to juggle several tasks.
• Preferred: experience using common AI tools such as ChatGPT or Microsoft Copilot to support problem solving and enhancement of work.

Conditions

Annual base salary ranges from $68,600.00 to $114,300.00. The United States salary range does not apply to Tampa, FL or any location outside the United States.

First shift, 0700 to 1530, with support for manufacturing as needed and occasional on-site weekend shifts.

Expected to move between the office and the shop floor as needed to support manufacturing.

Relocation assistance may be available based on business needs and eligibility.

You must be authorized to work in the U.S. for any employer.

U.S. work visa sponsorship, including TN, O-1 and H-1B, is not available for this role now or in the future.

Payments made to licensed physicians for recruiting expenses may be reported to the government under the Sunshine Act.

Benefits

• Eligible for the Global Performance Plan with a bonus target of 7.5% of base salary.
• 401(k) plan with company matching contributions and an additional retirement savings contribution.
• Paid vacation, holiday and personal days.
• Paid caregiver, parental and medical leave.
• Health coverage including medical, prescription drug, dental and vision.