Plant QA Specialist

Tjoapack•Clinton, TN

4d•Onsite

About The Position

The Plant QA Specialist is a hands-on quality role that serves as the primary quality representative on the production floor, ensuring packaging operations comply with SOPs, GMP requirements, and quality standards. The position is responsible for conducting inspections, reviewing batch records, supporting material release activities, managing deviation documentation, and assisting with investigations, CAPAs, risk assessments, and change controls. This role partners closely with production teams to provide real-time quality guidance, improve deviation reporting, and support continuous improvement initiatives. Ideal candidates have a bachelor's degree in a relevant scientific field, experience in quality or manufacturing environments, strong documentation and problem-solving skills, and familiarity with batch record review, controlled documents, and compliance processes.

Requirements

Bachelor's degree in Life Sciences, Food Science/Hygiene, Process Engineering, or a related scientific discipline preferred.
1–2 years of experience in a Quality Assurance, Quality Control, or quality-focused support role within pharmaceutical, healthcare, food, or other regulated manufacturing environments.
Experience performing shop-floor quality inspections and supporting production teams in a fast-paced manufacturing setting.
Working knowledge of GMP requirements, controlled documentation practices, and quality system processes.
Ability to review batch records, production documentation, and quality records for accuracy, completeness, and compliance.
Familiarity with deviation management, investigations, CAPAs, root cause analysis, risk assessments, and change control processes preferred.
Experience supporting material inspection, product release activities, and finished product quality checks.
Strong attention to detail with the ability to identify issues, maintain accurate records, and ensure compliance with established procedures.
Experience creating, reviewing, or updating SOPs, work instructions, forms, training materials, or other controlled documents is preferred.
Ability to provide real-time quality guidance to production personnel and effectively communicate quality expectations across teams.
Strong analytical, problem-solving, organizational, and time-management skills.
Demonstrated ability to support continuous improvement initiatives and drive quality-focused process enhancements.
Proficiency with Microsoft Office and electronic or paper-based document management systems.
Excellent verbal and written communication skills, with the ability to collaborate effectively across Quality, Operations, and Production teams.

Nice To Haves

Bachelor's degree in Life Sciences, Food Science/Hygiene, Process Engineering, or a related scientific discipline
Familiarity with deviation management, investigations, CAPAs, root cause analysis, risk assessments, and change control processes
Experience creating, reviewing, or updating SOPs, work instructions, forms, training materials, or other controlled documents

Responsibilities

Perform daily quality inspections during packaging operations to ensure compliance with SOPs, work instructions, and quality standards.
Serve as the first point of contact for production teams on quality-related questions and issues.
Provide real-time guidance and coaching to operators on GMP requirements and proper documentation practices.
Conduct finished product checks and monitor production activities to ensure products meet release requirements.
Review batch records and production documentation for accuracy, completeness, and compliance.
Support inspection, approval, and release of packaging materials and bulk products.
Maintain retain sample programs and support Right First Time (RFT) performance reporting.
Create, review, and update SOPs, work instructions, forms, and training documentation.
Review and approve minor deviations while ensuring timely and accurate documentation.
Support investigations of major deviations through data gathering and root cause analysis.
Assist with CAPAs, risk assessments, change controls, and other quality system activities.
Guide production staff on deviation reporting processes and compliance expectations.
Assist in developing and delivering GMP and quality-related training programs.
Support implementation of process improvements to enhance quality, compliance, and efficiency.
Participate in quality projects and help execute operational changes on the production floor.
Collaborate with cross-functional teams to identify opportunities for improving procedures and reducing errors.