Senior Technician, QC Sample Management
Bristol Myers Squibb
Summary
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 sample collection and distribution, inventory control, chain of custody, sample tracking, and sample delivery.
Job description
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.
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.
Qualifications
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.
Requirements
- Bachelor's degree or equivalent required, preferably in science
- 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 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
- Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals
- Ability to work in a Biosafety Level 2 (BSL-2) environment
Benefits
- Wellbeing Support
- Retirement Benefits
- Financial Protection Benefits
- Medical, Dental & Vision
- Life & Disability Insurance
- Flexible Time Off
- 11 Paid Company Holidays
- Paid Sick Leave
- Volunteer Days
- Summer Hours Flexibility
- Leaves of Absence
- Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.