Quality Assurance Systems Specialist

Description

 About Natureplex

Natureplex is a privately held pharmaceutical manufacturer that produces over-the-counter medicines and electrolytes. Founded in 2001, we offer proprietary brands, private-label products, and contract packaging services. With facilities in Memphis, Tennessee, and Olive Branch, Mississippi, we offer professional development and career growth opportunities.

We are seeking two experienced Quality Assurance Systems Specialists to join our team in Olive Branch, Mississippi. Ideal candidates will have a strong background in pharmaceutical quality systems, regulatory compliance, and quality documentation, and can independently review and approve critical quality activities.

Requirements

Position Summary

The Quality Assurance Systems Specialist supports and maintains the Quality Management System (QMS) to ensure compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and company standards. This position oversees quality system processes, reviews and approves quality documentation, supports audits and regulatory inspections, and collaborates with cross-functional departments to maintain product quality and drive continuous improvement.

Key Responsibilities

• Author, revise, and maintain Standard Operating Procedures (SOPs), work instructions, and controlled quality documentation.
• Review and approve GMP batch production records for accuracy, completeness, and adherence to established procedures.
• Prepare, review, and approve Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).
• Initiate, review, and approve Change Controls, including impact assessments, implementation, and closure activities.
• Investigate deviations, Out-of-Specification (OOS) results, customer complaints, and nonconformances.
• Develop, review, and approve Corrective and Preventive Actions (CAPAs), including effectiveness evaluations.
• Support supplier qualification and ongoing supplier quality management.
• Coordinate and support internal and external audits, FDA inspections, and responses to audit observations.
• Review quality data, identify trends, and recommend improvements to quality systems and processes.
• Oversee testing and inspection activities to verify adherence to established quality specifications.
• Support quality risk management activities and employee training initiatives.
• Collaborate with Manufacturing, Quality Control, Supply Chain, and Regulatory Affairs to resolve quality issues.

Required Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life Sciences, or a related scientific field.
• Minimum of five (5) years of Quality Assurance experience in an FDA-regulated manufacturing environment.
• Working knowledge of cGMP, FDA regulations, and Quality Management System (QMS) requirements.
• Experience with document control, investigations, Change Controls, CAPAs, and internal auditing.
• Proficiency in Microsoft Office applications.
• Strong analytical, organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities and meet established deadlines.

Preferred Qualifications

• Seven (7) or more years of Quality Assurance experience in an FDA-regulated manufacturing environment, preferably pharmaceutical or OTC manufacturing.
• Experience supporting FDA inspections, customer audits, or third-party audits.
• Experience with electronic document management systems or QMS software.
• Knowledge of quality risk management and continuous improvement methodologies.
• Experience reviewing and revising controlled quality documentation.

Work Schedule

• Monday through Friday.
• Minimum 40 hours per week.
• Occasional Saturday work as needed.

Benefits

Natureplex offers a comprehensive benefits package, including:

• Paid vacation
• Medical insurance with 80% coverage for employees and 20% for dependents
• Dental and vision insurance
• Short-term disability
• Voluntary life insurance
• Company-paid life insurance
• 401(k) plan with company matching
• Weekly pay
• ZayZoon – access to earned wages before payday

Equal Employment Opportunity

Natureplex provides equal employment opportunities and is committed to maintaining a safe, fair, and respectful work environment.

Natureplex participates in E-Verify.