QC Associate lll

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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.

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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

Company info

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