Senior Technician, QC Sample Management

Bristol Myers Squibb•Devens, MA

18h•Onsite

About The Position

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. 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. 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.

Requirements

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.
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.
Position Handles Hazardous Materials
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.

Nice To Haves

Knowledge of LIMS, ELN and laboratory data analysis systems preferred.
Experience with writing technical documents preferred.
Netherlands: Bachelor's degree /HLO in (bioanalytical) science preferred.
MLO level 4 with equivalent combination of work experience may be considered.

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.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays each year
160 hours of paid vacation annually for new hires
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day