Senior Technician, QC Sample Management

• Perform routine management of in-process, final product and stability samples and QC data throughout the sample lifecycle from receipt to disposition. Performs periodic sample and data inventory maintenance activities.
• Performs data compilation and review of GMP documentation in support of method trending.
• Compiles lot files for QC disposition review. Generate SOTR and manual CoA.
• Support document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train analysts on general job duties.
• Perform other tasks/duties as assigned.

Specific Knowledge, Skills, Abilities :

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Knowledge of LIMS, ELN and laboratory data analysis systems preferred.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers.
• Experience with writing technical documents preferred.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

Education/Experience/ Licenses/Certifications :

• • Bachelor's degree or equivalent required, preferably in science.

Netherlands: Bachelor's degree /HLO in (bioanalytical) science preferred. MLO level 4 with equivalent combination of work experience may be considered.

• 2+ years of relevant LIMS or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience in LIMS and knowledge of Chain of Identity and Chain of Custody.

• Ability to perform lifting tasks up to 20 lbs (9 kg) at floor and waist height. Ability to lift up to 10 lbs (4.5 kg) overhead as well as push or maneuver carts to transport materials between locations.
• Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
• Ability to independently don, doff, and wear required personal protective equipment such as but not limited to lab coat/frock, gloves, safety glasses/face shield for prolonged periods while performing laboratory work.
• Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals.
• Work may involve handling of dry ice, liquid nitrogen, and cryogenically cooled materials.
• Ability to use step stools while reaching and handling materials.
• Ability to work in a Biosafety Level 2 (BSL-2) environment.
• The laboratory employee is responsible for performing work safely in accordance with EHSS procedures. This includes identifying and controlling risks, proper use of personal protective equipment (PPE), safe handling of chemicals and biological agents, compliance with waste and emergency procedures, and active participation in training and safety programs.

WORKING CONDITIONS (US Only):

• The incumbent will be working around biohazardous materials and may be exposed to fluctuating and/or extreme temperatures on occasion.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position may be required to perform any other job-related duties as requested by management. Additional Job Requirements: Position Handles Hazardous Materials

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.