Quality Lab Technician I

Baxter•Marion, NC

About The Position

The Quality Laboratory Technician – Supplemental Destructive Testing (SDT) performs specialized destructive testing of sterile parenteral products. The work supports particulate matter investigations, process monitoring, product quality surveillance, and continuous improvement. The technician uses membrane filtration methods to detect and characterize visible particulate matter that may not be identified through conventional manual visual inspection. The role includes sample preparation, filtration, microscopy, particulate characterization, laboratory documentation, equipment maintenance, and data collection. Work is performed in compliance with current Good Manufacturing Practices (cGMP), site procedures, and applicable pharmacopeial requirements, with strict contamination-control practices in controlled laboratory environments. The position requires a high school diploma or GED; an associate degree in a relevant scientific discipline is preferred. One to three years of experience in a laboratory, manufacturing, quality, or regulated environment is preferred. The position may require occasional off-shift or weekend support for investigations and special studies. The estimated base salary is $40,000–$55,000 annually.

Requirements

High school diploma or GED.
Understanding of Good Documentation Practices (GDP).
Knowledge of cGMP requirements and quality systems.
Strong attention to detail and observational skills, including the ability to identify small particulate defects and visual anomalies.
Basic understanding of microscopy and laboratory testing principles.
Ability to maintain focus during repetitive inspection and testing activities.
Strong organizational and recordkeeping skills.
Effective verbal and written communication abilities.
Ability to work independently while following detailed procedures.
Proficiency with Microsoft Office applications and laboratory documentation systems.
Ability to sit or stand for extended periods and perform repetitive manual tasks requiring fine motor dexterity.
Ability to visually inspect small particles and defects under varying magnification levels.
Ability to wear required laboratory PPE for extended periods.
Ability to lift up to 25 pounds occasionally.
Correctable vision sufficient for microscopic and visual inspection activities.

Nice To Haves

Associate degree in Biology, Chemistry, Microbiology, Engineering Technology, Quality Sciences, or a related scientific discipline.
One to three years of experience in a laboratory, manufacturing, quality, or regulated environment.
Experience in pharmaceutical, medical device, biologics, or sterile manufacturing industries.
Experience performing visual inspection or particulate evaluation.

Responsibilities

Perform Supplemental Destructive Testing (SDT) on IV solution and sterile parenteral products using approved filtration methods.
Prepare samples, including product handling, unit manipulation, and filtration system setup.
Conduct membrane filtration testing in ISO 5 or similarly controlled environments.
Inspect filtration membranes visually and using stereomicroscopy.
Detect, classify, document, and trend particulate matter observations.
Maintain contamination-control practices through proper gowning, aseptic behaviors, and environmental awareness.
Perform clean blank filtrations and suitability checks before routine testing.
Operate and maintain laboratory equipment, including laminar flow hoods, vacuum filtration systems, stereomicroscopes, digital imaging systems, light measurement devices, and sample preparation equipment.
Capture particulate images and assist with particle characterization investigations.
Complete laboratory notebooks, worksheets, logbooks, electronic systems, and testing records accurately.
Review testing results for completeness and compliance with procedural requirements.
Support investigations involving visible particulate matter, foreign material, and product quality defects.
Assist with laboratory studies, method improvements, equipment qualifications, and continuous improvement projects.
Monitor laboratory cleanliness and maintain an organized, inspection-ready work environment.
Participate in laboratory training and qualification programs.
Support internal audits, regulatory inspections, and customer audits as required.
Identify and escalate atypical results, procedural deviations, or equipment concerns to Quality leadership.

Benefits

Medical and dental coverage starting on day one for eligible roles.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contributions and company matching.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence and paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program (EAP).
Childcare benefits.