Quality Assurance Specialist

Job Description

Job Description

QUALITY ASSURANCE (QA) SPECIALIST

Pay Range: $21.00 – $24.00 per hour

Location: Largo, FL

Schedule: 6a-3p. Must be willing to work overtime, holidays, and weekends as needed.

POSITION SUMMARY

We are seeking a Quality Assurance Specialist to support our Quality Assurance and Regulatory Compliance team in maintaining and enhancing compliance programs essential to our facility operations. This role is critical to ensuring our quality standards align with all applicable regulatory requirements and internal policies.

KEY RESPONSIBILITIES

• Support the Quality Management System (QMS) to meet requirements such as cGMP, CFRs, Food Safety/Defense, FSMA, FSVP, HACCP, and HARPC.
• Assist with the facility’s transition to NSF/ANSI 455-2 GMP standards for dietary supplements.
• Manage and maintain electronic documentation for domestic and international suppliers and manufacturers .
• Monitor and review the CAPA and deviation programs .
• Support the supplier/vendor qualification and re-qualification program , including outsourced labs and services.
• Assist the Training Department with new hire onboarding and ongoing employee training (Job-Specific, SOP, Annual GMP Training), ensuring documentation is accurate and compliant. Duties include scanning, copying, filing, and data entry.
• Support quality and regulatory filings and applications to ensure organizational compliance.
• Identify and implement continuous improvement initiatives to maintain third-party quality certifications (e.g., NSF, Organic, Kosher).
• Support the complaint handling program , including nonconforming materials/processes investigations and CAPAs to ensure timely completion.
• Prepare, revise, review, and approve SOPs and related documentation to ensure clarity, compliance, and efficiency.
• Conduct internal audits to ensure procedural adherence and department readiness (e.g., Glass & Brittle Plastic, GMP, Sanitation), including verifying corrective actions and educating staff on compliance.
• Maintain and request Quality Agreements, customer contracts, certifications, and attestations to support the QMS.
• Perform other duties as assigned .

REQUIRED QUALIFICATIONS

Education:

• High School diploma or equivalent required.
• Post-secondary education in a related field preferred.

Experience:

• Minimum 3 years of experience in a cGMP-regulated environment , such as drugs, cosmetics, dietary supplements, or medical devices.

Knowledge, Skills, and Abilities:

• Strong understanding of HACCP, HARPC, GMPs, GFSI, FSMA, FDA regulatory requirements .
• Knowledge of dietary supplement manufacturing (tablets, capsules, powders, liquids, gummies) is a plus.
• Ability to exercise sound technical judgment and collaborate effectively with production teams.
• Familiarity with system-related cGMPs, 21 CFR regulations , and SOPs.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
• Excellent proofreading, writing, and communication skills in English.
• Strong interpersonal skills to engage professionally across departments and with customers.
• Detail-oriented, able to follow both oral and written instructions.
• Self-starter with the ability to work independently, manage multiple projects under tight deadlines, and thrive in a fast-paced environment.
• Experience with Six Sigma, Lean, or similar methodologies is desirable.

#INDTP2