What are the responsibilities and job description for the Quality Assurance Engineer FL position at PL Developments?
- 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 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
PLD is a proud employer offering many corporate benefits, including:
- 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