Quality Assurance Systems Specialist

Natureplex•Olive Branch, MS

20h•Onsite

About The Position

The Quality Assurance Systems Specialist supports and maintains Natureplex’s Quality Management System (QMS) to ensure compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and company standards. The role oversees quality-system processes; reviews and approves quality documentation and critical quality activities; supports audits and regulatory inspections; and collaborates with cross-functional departments to maintain product quality and drive continuous improvement. The position is based in Olive Branch, Mississippi. The schedule is Monday through Friday, with a minimum of 40 hours per week and occasional Saturday work as needed. Natureplex is hiring two specialists.

Requirements

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life Sciences, or a related scientific field.
Minimum of five 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.

Nice To Haves

Seven 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.

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) and 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.