Quality Assurance Engineer FL

10400 NW 29th Terrace
Miami, FL 33172, USA

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

JOB QUALIFICATIONS:

• 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

POSITION 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

PHYSICAL REQUIREMENTS:

• Work safely and follow all OSHA regulations and company safety policies and procedures
• Works frequently in a lab environment, handling of 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

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

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.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.