Bristol Myers Squibb Company

Quality Control Associate lll

Location
Bothell, WA, United States
Posted
Sep 05, 2020
Ref
R1524999
Discipline
Quality, Quality Control
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.

THIS IS A WED - SAT AM SHIFT (6a-4:30p)

PURPOSE AND SCOPE OF POSITION:

The primary focus of the Quality Control Associate III role will be to support product lot release and in-process testing within a cGMP environment. Additionally, this role will provide technical support and troubleshooting for the support of lot release, in-process, and stability testing.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:
  • BS in a scientific discipline.


Experience
  • 6+ years of analytical QC testing within a regulated environment
  • Experience working in a regulated (GxP) environment and familiarity with various Quality Systems preferred.
  • Demonstrated success working in a high-performing, business results-driven environment.


Knowledge, Skills, and Abilities
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects without supervision.
  • Strong analytical and communication skills.
  • Computer proficiency as well as strong scientific and organizational skills.
  • Experience working in a GMP environment.
  • Demonstrated success working in a high-performing, business results-driven environment.
  • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
  • Ability to maintain flexible intellect and adjust to a dynamic work environment.
  • Detail-oriented with strong time-management skills.


DUTIES AND RESPONSIBILITIES:

Key Responsibilities
  • Perform or support cGMP lot release, in-process, and stability testing using various software packages.
  • Ensure timely completion of testing and tasks as assigned.
  • Perform assay and form review.
  • Lead assay transfer and method validation of by representing site QC in cross-site validation protocols and providing data to support final reports.
  • Participate in cross-functional training.
  • Author and revise test methods, SOPs, raw material specification, and/or sample plans as appropriate.
  • Identify and facilitate continuous improvements.
  • Execute technical transfer and validation protocols for QC assays.
  • Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner.
  • Assist in the implementation of new assay methodologies and the associated instrumentation.
  • Identify and support initiation and completion of Deviations, CAPAs and Laboratory Investigations.
  • Act as a lead in small to medium scale projects.
  • Act as owners for Deviation, CAPA, Laboratory Investigations, and Change Controls records.
  • Train other on QC processes and procedures


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 will be required to perform any other job-related duties as requested by management.

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.