QA Specialist I

Essential Duties and Responsibilities

• Lead and manage investigations for deviations, non-conformances, and customer complaints, including root cause analysis, product impact assessment, and timely closure.


• Drive and monitor CAPA activities to ensure effective, compliant, and sustainable corrective actions.


• Support validation activities and maintain compliance with cGMP (21 CFR 211) and ALCOA+ data integrity standards.


• Support change control, SOP development, and batch record review to ensure accuracy and regulatory compliance.


• Serve as SME during internal, customer, ISO, and FDA audits, including preparation and response support.


• Perform risk assessments and trend analysis (including complaints) and collaborate cross-functionally to strengthen quality systems and drive continuous improvement.

Knowledge, skills, and abilities

• Strong knowledge of FDA regulations (21 CFR 210/211) and GMP.


• Experience with validation principles and data integrity (ALCOA+).


• Strong investigation and root cause analysis skills.


• Experience handling customer complaints and regulatory reporting expectations.


• Excellent technical writing skills and organizational skills.


• Ability to manage multiple priorities.


• Strong communication and teamwork skills.


• Pay range $28.00 - $33.00 per hour.

Education and/or Experience

• Bachelor’s degree in science, Engineering, or related field.


• Minimum 3–5 years of experience in Quality Assurance within a pharmaceutical, OTC, cosmetic, or regulated manufacturing environment.


• Experience with deviations, CAPA, investigations, validation (IQ/OQ/PQ, cleaning), and regulatory/customer audits.


• Computer literate, with proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.


• Experience supporting audits, customer visits, customer meetings, and classroom training experience.


• Strong communication and public speaking skills.


• Experience using and navigating ERP systems (SAP+).

PLZ Corp offers a robust suite of benefits including:

• Medical, Dental & Vision benefits.


• Company paid Life and Short-Term disability.


• Voluntary benefits include additional life, disability, and hospital/accident insurance.


• 401k & company provided match.


• Paid Time Off


• Bonus incentive programs (Note, bonuses are subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status or other protected status. EEOE/M/F/Vet/Disabled. All your information will be kept confidential according to EEO guidelines.