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

Nephron Sterile Compounding Center LLC; West Columbia (SC); On-site; USD 36,000 - 60,000; Full time

Job summary

Nephron Sterile Compounding Center LLC in West Columbia, South Carolina, seeks a detail-oriented Quality Assurance Associate to perform visual inspections of drug products during packaging and ensure accuracy of batch records. You will monitor packaging areas for cGMP and SOP compliance, release finished products after inspection, and support QA activities across related processes.

Candidates should have a high school diploma or GED, 1 year QA experience, knowledge of GMP, and proficiency with

Qualifications

• High school diploma or GED is required.
• Minimum of 1 year QA/Production experience in pharmaceutical industry.
• Knowledge of GMP is preferred.
• Strong attention to detail and excellent written and verbal communication.
• Proficiency with MS Outlook, Word, and Excel.
• Ability to work in a cGMP environment.

Responsibilities

• Monitors and performs visual inspections and finished product inspections.
• Perform visual inspections of Outsourcing products.
• Monitor all packaging areas and personnel for adherence to cGMP, SOPs and safety regulations.
• Keep line and work station clean and orderly to ensure no product line contamination.
• Perform line clearance including equipment, components and label verification.
• 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 all completed batch record documentation to ensure completion and compliance with Good Documentation Practices.
• Perform QA functions for Accraply, HP, and Autoclave processes.
• Cross-train in other department(s) to expand job knowledge.

Skills

Attention to detail

MS Outlook

MS Word

MS Excel

Communication skills

Teamwork

Quality assurance experience

Adaptability

Education

High School Diploma or GED

Job description

Description

Job Purpose:

• Perform Quality Attributes and Visual Inspection of drug product through the packaging process including Visual Inspection in compliance with company policies / procedures, FDA and cGMP regulations.
• Ensures the accuracy and completeness of manual and electronic batch records.
• Assists with additional work duties or responsibilities as evident or required.

Essential Duties and Responsibilities:

• Monitors and performs visual inspections and finished product inspections.
• Perform visual inspections of Outsourcing products.
• Monitor all packaging areas and personnel for adherence to all cGMP, SOP’s and safety regulations.
• Keep line and work station clean and orderly to ensure no product line contamination.
• Perform line clearance including equipment, components and label verification.
• 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 all completed batch record documentation to ensure completion and compliance with Good Documentation Practices.
• Perform QA functions for Accraply, HP, and Autoclave processes.
• Cross-train in other department(s) to expand job knowledge.

Supplemental Functions:

Shop Floor QA Accountabilities

• Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.
• Assist with development of solutions for chronic problems within quality assurance
• Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.
• Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.
• Assist in other activities (as needed) for Quality Assurance management.

Job Specifications and Qualifications:

Knowledge & Skills:

• Detail oriented.
• Good computer skills in MS Outlook, MS Word, and MS Excel
• Good visual acuity and observation skills.
• Good written, oral and comprehensive communication skills.
• Ability to handle diversity of projects.
• Specific expertise, skills and knowledge within quality assurance gained through education and experience.
• Ability and willingness to change direction and focus to meet shifting organizational and business demands.
• Ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.

Education/Experience:

• High School Diploma or GED
• Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred.

Working Conditions / Physical Requirements:

• Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs.), vision (20/20), standing (40%), sitting (40%), walking (20%), typing, and hearing.