Facilities Compliance Associate I

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.

PURPOSE AND SCOPE OF POSITION:

The Facilities Compliance Associate will be responsible for all duties listed below, under the minimal direction of the Facilities Compliance Specialist.

The Associate will support Facilities compliance by overseeing GxP documentation including creation and revision of Standard Operating Practices (SOPs) and associated Work Instructions (WIN). The Associate will be responsible in performing F&E related deviation investigations and CAPA.

DUTIES AND RESPONSIBILITIES:

Key Responsibilities

Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, GMP, and safety guidelines.

Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, GMP’s, and safety.

Participate in the development and revisions to the Facilities & Engineering training program.

Write and revise Facilities SOPs as required.

Execute Deviations, CAPA plans

Excellent communication skills, both verbal and written.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

Requires a Bachelor’s degree or equivalent

Experience

Must have a minimum of 0-2 years’ experience performing deviation investigations and CAPA

0 -2 years directly related experience in cGMP manufacturing facility, Biotechnology, Medical Devices or Pharmaceuticals Company.

Must have 0-2 years of experience with Computerized Maintenance Management System (CMMS) and Building Automation System (BAS).

Must have demonstrated ability to effectively support operations in a GMP and/or GLP environment, preferably with Aseptic Technique and clean room protocol experience.

Knowledge, Skills, and Abilities

Must have the ability to work with people at varying levels within the company and varying technical backgrounds.

Demonstrated ability to follow SOP’s and works within GMP guidelines.

Must have knowledge of technical writing.

Proactive, highly organized, detail oriented and self-directed.

Ability to work independently and manage multiple tasks.

Proficient in Microsoft Office

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