Specialist, QA Batch Review

Qlty Assurance Methods

icon-location-marker Jersey City - NJ - US
Posted 33 days ago Full_time R1520590

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 Specialist is responsible for quality and disposition activities in accordance with Celgene policies, standards, procedures and Global cGMP.  Functional responsibilities include performing incoming material release and product release, ensuring accurate and timely maintenance and review of manufacturing batch record documentation, and performing document issuance for manufacturing.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities

  • Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Must possess an independent mindset.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
  • Work is self-directed.
  • Confident in making decisions for non-routine issues.
  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
  • Proposes solutions for complex issues and works with management to resolve.   Follows established procedures and performs work as assigned.
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Is recognized Subject Matter Expert within the group.
  • Provides guidance to other employees in interpretation of complex data.
  • Understands continuous improvement and improves efficiency and productivity within the group or project.
  • Builds relationships internally within and with 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 effectively multi-task.
  • Knowledge of US and global cGMP requirements.
  • Excellent verbal and written communication skills.

DUTIES AND RESPONSIBILITIES

  • Review and approval of executed batch records.
  • Issue production batch records and product labels to Operations.
  • Responsible for disposition of incoming production materials.
  • Responsible for release activities for site manufactured drug product.
  • Provide oversight of QA shop floor program.
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

EDUCATION AND EXPERIENCE (As Applicable)

Relevant college degree preferred, minimum of five years of experience in the pharmaceutical or related industry.

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.

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.