com/careers or visit https:

//youtu.be/XYNIFpLQIJY The Quality Specialist is responsible for supporting quality systems, documentation, audits & training in GMP environment adhering to the ISO and FDA GMP regulations and follows SOPs, GMP, GLP and GDP. Additional responsibilities as Quality Manager back up.

Key Responsibility:

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.

Qualifications:

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. 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+).

WORK ENVIRONMENT & PHYSICAL REQUIREMENTS

Office/Manufacturing environment

COMPENSATION

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $70,000 in our lowest geographic market up to $80,000 . in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Dependent on the position offered, other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. PLZ Corp offers a robust suite of benefits including: Medical, Dental & Vision benefits. Company paid Life and Short-Term disability. Voluntary benefits including additional life, disability, and hospital/accident insurance. 401k & company provided match. 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