Sr QA Specialist and Quality Engineer FL

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:

Seeking an experienced QA professional to lead quality systems, support regulatory compliance, and drive continuous improvement in a fast-paced, cGMP-regulated environment. Requires 7+ years in QA, strong knowledge of FDA regulations, and expertise in root cause analysis and validation processes.

Work Schedule: Monday-Friday 8:00 am - 4:30 pm

JOB QUALIFICATIONS:

• BS on Science, Engineering or related field from an accredited college or university


• CQE certification, preferred


• Minimum of 7 years of relevant experience, preferably in a pharmaceutical Quality Assurance environment or a similar regulated industry


• Strong knowledgeable of cGMP’s, FDA regulations, and guidance


• Experience with regulatory inspections (e.g., FDA, DEA)


• Proficient in investigations techniques for determining root cause, implementing corrective/preventive actions, and assessing their effectiveness


• High attention to detail


• Excellent interpersonal and communication skills


• Strong written and verbal communication skills


• Effective organizational and time management skills


• Ability to work in a fast-paced, dynamic environment and meet deadlines


• Proficient in Microsoft Word, Excel and Power Point


• Self-starter with the ability to work independently


• Familiarity with Quality System software such as Agile, TrackWise, and SAP

POSITION RESPONSIBILITIES:

• Analyze data from production and laboratories, reports deviations (Manufacturing, Laboratory) and support departments in identifying root causes, recurring issues, and resolving complex quality problems


• Evaluates trends and recommends improvements in production and site operation


• Oversees Quality Systems related to the Product/ Technology Transfer processes


• Ensure compliance with Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements in a regulated manufacturing environment


• Support the training department in assessing and updating Quality competencies


• Review and approve validation protocols and reports for equipment, processes, and computer systems.


• Support the deviation system from Quality perspective to ensure adequacy of root cause analysis, correctives/preventives actions, and product impact assessments


• Assist in the creation and review of new production and packaging records


• Support the production department in preparing and writing deviations/investigations


• Performs Annual Product Reviews (APRs) for site-manufactured products


• Prepare site Quality Metrics


• Represent Quality Assurance Manager in meetings and different forums.


• Perform other tasks as assigned by the QA Supervisor, QA Manager or the Quality Director

PHYSICAL REQUIRMENTS:

• Comply with all company policies and procedures, including safety rules and regulations


• Work is performed in a standard office environment


• Must be able to stand, walk, bend, reach, stoop, and lift objects up to 25 pounds

BENEFITS:

PLD is a proud employer offering many corporate benefits, including:

• Medical and Dental Benefits


• Vision


• 401k with employer match


• Group Life Insurance


• Flexable Spending Account


• 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.