Quality Assurance Specialist Label Control Cell Therapy

Location
Summit West, NJ, United States
Posted
Sep 17, 2020
Ref
R1529680
Required Education
Bachelors Degree
Position Type
Full time
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 Quality Assurance Label Control Specialist at the Summit, NJ S12 Cell Therapy manufacturing facility is responsible for supporting site Label Control activities at S12 in accordance with BMS policies, standards, procedures and Global cGMPs. Functional responsibilities include performing in-process and drug product label printing activities; ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO).

The Quality Assurance Label Control organization is responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives. This organization supports the S-12 facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
  • Must have knowledge and experience with GMP, Quality, and compliance.
  • Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.
  • Requires moderate direction to complete more complex tasks; completes routing tasks with little or no supervision.
  • Must be time organized and possess an independent mindset.
  • Good understanding of electronic document management and manufacturing execution systems.
  • Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
  • Confident in making decisions for non-routine issues.
  • Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies.
  • Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
  • Builds relationships and effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
  • Contributes to goals within the work group.
  • Able to recognize conflict and notify management with proposed recommendations for resolution.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Able to produce data reports with precision.
  • Able to muti-task.
  • Able to support internal and health authority inspections of facility


Education and Experience:

B.S. Degree required,

Minimum 2 years of relevant Quality Assurance work experience required

QA Document Control Experience is highly preferred.

Commercial Manufacturing experience in a GMP regulated environment is highly preferred.

Strong Attention to Detail mindset is a must

Equivalent combination of education and experience acceptable

DUTIES AND RESPONSIBILITIES:
  • Supports all activities for the Quality Assurance Label Control group.
  • Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.
  • Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.
  • Coordinates with production teams to ensure timely issuance of labels.
  • Performs training of label control and issuance requirements for internal personnel as needed.
  • Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.
  • Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
  • Provides support during internal and health authority inspections and audits of facility.
  • Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
  • Performs supplemental investigations/projects as required by Management.
  • Maintains knowledge of current GMPs and regulatory guidelines.


WORKING CONDITIONS (US Only):

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10%of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

BMSCART

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.