QO Visual Inspector Tier I (Shift 3 6:00pm - 6:30am)

Nephron Sterile Compounding Center LLC•West Columbia, SC

About The Position

Perform Quality Attributes and visual inspection of drug product through the packaging process in compliance with company policies and procedures, FDA requirements, and cGMP regulations. Ensure the accuracy and completeness of manual and electronic batch records. Assist with additional duties and responsibilities as needed. The role monitors and performs visual and finished-product inspections, including inspections of outsourced products. It monitors packaging areas and personnel for compliance with cGMP, SOPs, and safety requirements; maintains clean, orderly work areas to prevent product-line contamination; performs line clearance and equipment, component, and label verification; supports validation and manufacturing studies; and organizes work during lot changeovers. The position releases finished product for packaging after visual inspection, reviews completed batch records for completeness and Good Documentation Practices compliance, and performs QA functions for Accraply, HP, and Autoclave processes. Cross-training in other departments is expected. As part of shop-floor QA, the role helps monitor production areas, supports solutions to recurring quality problems, and communicates quality observations, issues, discrepancies, and policy or procedure violations to Quality Management. Employees are responsible for product quality and timely notification of management about regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions. The role stays current with FDA requirements and relevant SOPs and assists Quality Assurance management as needed.

Requirements

High school diploma or GED.
At least 1 year of pharmaceutical Quality Assurance or production experience, or 2 years of related experience preferred.
Detail-oriented.
Good computer skills, including MS Outlook, MS Word, and MS Excel.
Good visual acuity and observation skills.
Good written, oral, and comprehensive communication skills.
Ability to handle a variety of projects.
Quality Assurance-specific expertise, skills, and knowledge gained through education and experience.
Ability and willingness to change direction and focus to meet shifting organizational and business demands.
Ability to contribute to an environment that values people and encourages trust, teamwork, open communication, participation, learning, feedback, and recognition.
Physical ability to reach from waist to head, bend from waist to floor, lift up to 25 pounds, type, and hear; requires 20/20 vision.
Position activity includes standing 40%, sitting 40%, and walking 20%.

Nice To Haves

Knowledge of GMP.
Pharmaceutical Quality Assurance or production experience (minimum 1 year) or 2 years of related experience is preferred.

Responsibilities

Monitor and perform visual inspections and finished-product inspections.
Perform visual inspections of outsourced products.
Monitor packaging areas and personnel for adherence to cGMP, SOPs, and safety regulations.
Keep the line and workstation clean and orderly to prevent product-line contamination.
Perform line clearance, including verification of equipment, components, and labels.
Support validation and manufacturing studies, including special sampling and testing.
Organize workload during lot changeovers for efficient execution.
Release finished product for packaging after visual inspection.
Review completed batch records for completeness and compliance with Good Documentation Practices.
Perform QA functions for Accraply, HP, and Autoclave processes.
Cross-train in other departments to expand job knowledge.
Help monitor production areas and personnel for cGMP, SOP, and safety compliance.
Assist with developing solutions to chronic Quality Assurance problems.
Communicate quality-related observations, issues, problems, discrepancies, and policy or procedure violations to Quality Management.
Stay current with FDA requirements and relevant departmental SOPs, and observe procedures being performed.
Notify responsible management in a timely manner about regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions.
Assist Quality Assurance management with other activities as needed.