PL Developments · 1 month ago
Quality Assurance Engineer FL
Miami, Florida, United States
Full-time
Onsite
Entry, Mid Level
2+ years expPL Developments is a leading manufacturer, packager, and distributor of over-the-counter pharmaceutical products and consumer healthcare goods. We are seeking a detail-oriented QA Engineer to join our Pharmaceutical Quality Assurance team, responsible for maintaining FDA and cGMP compliance for OTC pharmaceutical manufacturing operations while supporting quality systems, investigations, and process improvements.
BiotechnologyManufacturingPackaging ServicesPharmaceuticalProduct Management
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
Qualification
Required
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
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
Company
PL Developments
PL Developments manufactures, packages, and distributes over-the-counter pharmaceutical products and consumer healthcare goods.
1001-5000 employees
H1B Sponsorship
PL Developments has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2023 (1)
2022 (2)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$500M2024-10-28Debt Financing· $500M
Leadership Team
Mitch Singer
President & CEO
Recent News
2025-08-13
2025-03-03
Company data provided by crunchbase