Senior Technician, QC Sample Management - Devens MA

United States·Devenssenior

OperationsManagement

0 views0 saves0 applied

Apply Now

Quick Summary

Key Responsibilities

Perform routine management of in-process, final product and stability samples and QC data throughout the sample lifecycle from receipt to disposition.

Technical Tools

OperationsManagement

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

The QC Sample Management Technician is responsible for the movement and control of QC samples and materials, including in-process, finished drug product, characterization, retain, and stability samples processed through the QC laboratories. This includes, but is not limited to, sample collection and distribution, inventory control, chain of custody, sample tracking, and sample delivery.

SHIFT

This role works from 6AM to 6PM following a 12-hour rotating shift (36/48 hours over a 2-week period) which includes working every other weekend, holidays falling on scheduled workdays, and during adverse weather conditions in support of QC and the manufacturing facility. Flexibility to work irregular hours and short notice overtime may be required

.Job Description: Responsible for performing 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.

Duties/Responsibilities:

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.

Responsibilities

~3 min read

Qualifications:

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.

Job Safety Requirements & Essential Physical Demands 

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.

Compensation Overview:

Devens - MA - US: $36.46 - $44.18per hour