Quality Assurance Engineer FL

PL Developments CareersMiami, FL
20hOnsite

About The Position

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods. 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

Requirements

  • 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

Responsibilities

  • 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

Benefits

  • 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
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