Quality - Laboratory Technician

Position Title: Quality - Laboratory Technician

Work Location: Summit West NJ

Assignment Duration: 12 Months

Work Schedule: Mon- Fri(normal Business hours)

Work Arrangement: 100% onsite

Position Summary:

Support daily operations in the Critical Reagent and Raw Material laboratories by maintaining inventory, managing samples, supporting pack out activities, and ensuring materials are available for QC testing according to established schedules.

Perform laboratory support activities in compliance with cGMP, GDP, EHS, and site procedures, including accurate documentation, safe material handling, and adherence to lab housekeeping expectations.

Collaborate with QC, ASAT, EHS, and cross-functional partners to maintain inspection readiness, support lab walkthroughs, and promote a safe, compliant, and organized laboratory environment.

Key Responsibilities:

* Maintain inventory for Critical Reagent and Raw Material labs, including cycle counts, material stocking, reconciliation, inventory organization, and timely escalation of shortages, discrepancies, or expired materials.

* Support sample management activities, including receipt, labeling, storage verification, sample movement, chain-of-custody support, and maintaining appropriate storage conditions based on material requirements.

* Coordinate and perform pack out activities for samples and materials, ensuring required documentation, packaging, labeling, temperature control, and safety requirements are followed.

* Clean and maintain designated laboratory equipment, work areas, carts, storage locations, and shared lab spaces according to approved procedures and housekeeping expectations.

* Support routine lab walkthroughs in Critical Reagent and Raw Material labs to identify housekeeping, inventory, safety, documentation, labeling, storage, or compliance gaps and assist with timely closure of observations.

* Participate in EHS walkthroughs and safety readiness activities, including verification of PPE, waste handling practices, chemical and biological material storage, spill kit availability, sharps containers, and general laboratory safety expectations.

* Record inventory, sample handling, cleaning, pack out, and walkthrough-related information accurately, clearly, and contemporaneously in accordance with GDP requirements.

* Work collaboratively with QC analysts, managers, EHS, and support functions to ensure materials, samples, equipment, and lab spaces remain ready for testing, audits, inspections, and daily operations.

* Follow all applicable SOPs, safety procedures, gowning requirements, waste disposal expectations, and site policies while working in cGMP laboratory areas, including areas that may contain blood-derived or biological materials.

* Perform other duties as assigned to support QC laboratory operations and continuous improvement initiatives.

Qualification & Experience:

* Required min High school diploma/GED with 1-3 years of laboratory operations, manufacturing, inventory, or sample management experience; OR Associate/Medical Technical degree with 2-3 years of relevant experience; Bachelor's degree in biology, chemistry, medical technology, or related scientific discipline preferred.

* General understanding of cGMP, GDP, FDA-regulated environments, and EHS expectations.

* Experience with inventory control, sample handling, material movement, pack out, or laboratory support activities preferred.

* Experience with SAP ERP system preferred.

* Basic mathematical skills and ability to perform accurate counts, reconciliations, and documentation reviews.

* Ability to follow SOPs, safety procedures, gowning requirements, and material handling instructions in a regulated laboratory setting.

* Proficiency with Microsoft Office applications and ability to learn site-specific systems used for inventory, sample tracking, and documentation.

* Strong attention to detail with ability to maintain accurate inventory, sample, cleaning, and walkthrough records.

* Effective organizational and time-management skills to support multiple lab activities, priorities, and deadlines.

* Good written and verbal communication skills, including timely escalation of safety, inventory, sample, or compliance concerns.

* Ability to work independently and collaboratively with QC, ASAT, EHS, and cross-functional partners.

* Demonstrated commitment to safety, compliance, housekeeping, and inspection readiness.

* Ability to lift, move, organize, and handle laboratory materials and supplies within site safety requirements.

Working Conditions & Physical Demands (If Applicable):

Lab w/ blood & animal

Position Handles Hazardous Materials

Additional Information (If Applicable):

Reporting Relationship - Reports to QC Manager, S6A Network QC Lab