Quality Assurance Engineer FL

SUMMARY

We are seeking a detail‑oriented QA Engineer to join our Pharmaceutical Quality Assurance. In this role, the Quality Assurance Engineer plays a key role in maintaining FDA and cGMP compliance for OTC pharmaceutical manufacturing operations. This position supports quality systems, investigations, and process improvements to ensure consistent product quality.

Work Schedule:

Monday - Friday 8:00 AM - 4:30 PM

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related field
• 2–5+ years of experience in Quality Assurance within pharmaceutical or OTC manufacturing
• Strong knowledge of cGMP, FDA regulations, and quality systems
• Experience with deviation investigations, CAPA management, and change control
• Familiarity with OTC drug manufacturing and labeling requirements
• Excellent written and verbal communication skills
• Strong attention to detail and documentation skills
• Ability to work cross‑functionally in a regulated environment

• Ensure compliance with FDA regulations (21 CFR Parts 210, 211), cGMPs, and company quality systems
• Review and approve batch records, deviations, investigations, CAPAs, and change controls
• Provide quality oversight for manufacturing, packaging, labeling, and testing operations
• Investigate nonconformances, deviations, and complaints, and lead root cause analyses
• Support internal audits, FDA inspections, and third‑party regulatory audits
• Review and approve SOPs, protocols, validation documents, and quality records
• Collaborate with Manufacturing, QC, Regulatory, and Engineering teams to resolve quality issues
• Ensure proper implementation of process validation, cleaning validation, and equipment qualification
• Monitor quality metrics and support continuous improvement initiatives
• Provide QA guidance and training to manufacturing and support staff
• Support product releases and ensure documentation accuracy and completeness

• Work safely and follow all OSHA regulations and company safety policies and procedures
• Works frequently in a lab environment, handling chemicals
• Employees are required to wear eye protection and lab coats while in the lab area
• Ability to frequently lift and/or move up to 25 lbs
• Ability to occasionally lift and/or move up to 35 lbs
• Ability to regularly stand, sit, and walk to perform tasks

• Medical and Dental Benefits
• Vision
• 401K with employer match
• Group Life Insurance
• Flex Spending Accounts
• Paid Time Off and Paid Holidays
• Tuition Assistance
• Corporate Discount Program
• Opportunities to Flourish Within the Company

PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.