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Job Opening: QC Technician – Endotoxin/LAL Testing Focus

Schedule: Monday–Friday | 9:00 AM – 5:00 PM

Type: 4-Month Contract-to-Hire (or Direct Hire for Right Candidate)

Pay: $31–$33/hr (Contract) | $65,000–$70,000 (Full-Time Conversion)

Start Date: Immediate or within 2 weeks

Join a Fast-Growing Medical Device & Cell Therapy Company

+ We’re seeking a detail-oriented QC Technician to join a rapidly growing, FDA-regulated medical device company specializing in regenerative therapies. If you have hands-on experience performing LAL/endotoxin testing- This is a high-impact role with long-term potential.

+ This position supports quality operations in a GMP/ISO manufacturing environment.

What You'll Do

+ Perform analytical testing on raw materials, in-process, and finished product samples (including PRP, Platelet Rich Plasma)

+ Execute LAL testing (endotoxin detection) following validated protocols

+ Conduct environmental monitoring in cleanroom settings (viable/non-viable particulates) used for sterile PRP or device production

+ Support validation studies and maintain traceability and documentation,

+ Calibrate and maintain instruments used in GMP production of PRP

+ Assist with deviation, OOS, and CAPA investigations

+ Ensure full compliance with FDA, GLP, GMP, and ISO 13485 standards

What We're Looking For

+ Associate’s or Bachelor’s degree in Biology, Chemistry, Microbiology, or related field

+ 1–3 years of QC lab experience in medical device, biologics, pharmaceutical, or cell therapy manufacturing environments

+ Experience with LAL / endotoxin testing-especially on PRP

+ Experience with endotoxin testing for injectables, cell therapies, IV treatments, vaccines, sterile biologic materials, medical devices or catheters would also translate.

+ Familiarity with environmental monitoring and basic analytical testing (e.g. pH, conductivity)

+ Understanding of FDA QSR, ISO 13485, and cleanroom operations

+ Detail-oriented with strong documentation and time management skills

+ Microsoft Office proficiency; LIMS experience is a plus

Why This Role?

+ Hands-on exposure to cutting-edge regenerative therapies

+ Join a team working with regenerative therapies.

+ Real opportunity for full-time conversion with career advancement

+ High-impact work in a regulated GMP/ISO lab environment

+ Mentorship and ongoing training in QC methods.

System One is a leader in outsourced services and workforce solutions across regulated industries. We are proud to be an Equal Opportunity Employer and support an inclusive workplace for all applicants.

Keywords

PRP, platelet rich plasma, platelet, platelets, plasma, gel-clot, chromogenic, turbidimetric, environmental monitoring, microbiology, endotoxin, LAL, limulus, amebocyte, lysate, USP 85, EP 2.6.14, JP 4.01

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Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.