Quality Control Supervisor Sample Management Second Shift Cell Therapy

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At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

The Supervisor, Sample Management-Quality Control Systems and Services is responsible for maintaining and overseeing the sample management program and personnel. Sample Management supports the QC Analytical, QC Molecular and QC Microbiology laboratories as well as the Manufacturing Unit for providing sample support. Responsibilities include sample tracking, storage and delivery plus retain and inventory management. This position has direct reports. The CAR T facility in Summit, New Jersey operates 7-days a week, and some work may include holidays and weekends. The Supervisor will also serve as a backup for management, as needed. This is a Second Shift position with working hours Monday-Friday, 4:00PM - 12:30AM.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

Experience working in a highly regulated environment; aseptic knowledge a plus

Understands and adheres to Good Documentation Practices

Proficient in the use of LIMs and sample tracking systems

Advanced ability to accurately understand, train, follow, interpret and apply global regulatory and cGMP requirements while working

Self-directed; organized and able to prioritize work as schedules change

Good communication skills; provides feedback; conducts performance reviews

Ability to interact with regulatory inspectors as the subject matter expert (SME)

Ability to author, review, revise SOPs and other documents

Able to author and conduct Deviations, Investigations, CAPAs and Change Controls

Ability to create process improvements and improve efficiencies

Train others in a team environment

Acts as designee in the absence of the Senior Supervisor or next line function

DUTIES AND RESPONSIBILITIES

Oversees the handling of test samples throughout the sample lifecycle process from receipt, storage, dispensing, shipping, transfer and destruction in accordance with written and approved procedures

Maintains and updates the daily task schedules; informs other shifts of sample changes

Manages long term storage of retains and inventory where necessary

Trains personnel in Sample Management on approved procedures

Maintains chain of custody and chain of identity for samples in accordance with cGMPs

Collaborates with other departments to ensure successful sample support is maintained

Trains and mentors associates in Sample Management

Provides performance feedback for Sample Management personnel

Assists in conducting investigations where necessary; implements CAPAs and process improvements

Reviews the daily work performed; reviews forms; reviews shift reports

Critical thinker who can troubleshoot while working

Able to prioritize work schedules for the group and make changes as the business needs change

Ensure that samples and other materials are appropriately labeled and follows written procedures

Establish new SOPs and make updates to current SOPs related to Sample Management

Delegates tasks to personnel appropriate to their skill level

Provides feedback to management for direct reports' performance

Maintain metrics where needed for Sample Management workload

EDUCATION AND EXPERIENCE (As Applicable)

Bachelor's degree required, preferably in Chemistry, Microbiology, or related s cience.

Advanced d egree preferred.

5-8 y e ars o f relevant Quality Assurance and/or Quality Control work experience, in a GMP regulated environment, is required.

2 years of Leadership/Supervisory responsibility, overseeing direct reports, is required.

Strong Communications Skills (both verbal and written) are required

Experience with Audits and Inspections is highly preferred.

An equivalent combination of education and experience may substitute.

WORKING CONDITIONS:

The incumbent will be working around biohazardous materials and chemical agents

The incumbent will be working in a laboratory setting up to 6 hours per day.

The incumbent will be doing moderate lifting; 10 -15 lbs occasionally

The incumbent must be able to distinguish colors and possess correctable vision to 20/20,

The incumbent will be exposed to different temperatures for storing samples

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1526523_EN

Updated: 2020-06-17 00:00:00.000 UTC

Location: Summit,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com