Associate Specialist, QA

Location
Bothell, WA, United States
Posted
Sep 29, 2020
Ref
R1526479
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 1:30p-midnight Shift

The Quality Associate Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (JuMP). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. This role directly supports JuMP's release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at JuMP with an emphasis on supporting Manufacturing with a Quality perspective within a regulated cGMP environment.

The primary focus of the QA Associate Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture at JuMP by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:
  • Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree is required.


Experience
  • 4+ years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
  • Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
  • Hands-on experience with batch record review and product disposition is preferred.


Knowledge, Skills, and Abilities
  • Strong computer skills with Word and Excel and other electronic manufacturing systems.
  • Detail oriented team player with effective planning, organization and execution skills.
  • Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
  • Good organization and time management skills.
  • Ability to work in a high paced team environment.
  • Strong written and verbal skills.


DUTIES AND RESPONSIBILITIES:

Key Responsibilities
  • Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
  • Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.
  • Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
  • Review deviations, product non-conformities, and GMP investigations to ensure adequate.
  • Own department events and minor deviations.
  • Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
  • Oversee manufacturing operations during patient material receipt and drug product pack out.
  • Support the review and approval of incoming raw materials, routine preventive and calibration of equipment.
  • Support internal and external audits, including documenting observations and implementation of corresponding CAPAs.
  • Lead small scope projects as assigned.
  • Revise Standard operating Procedures as needed.
  • Train and mentor junior team members.


WORKING CONDITIONS (US Only):
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
  • Work in areas that may have strong magnets.
  • May work in areas with exposure to vapor phase liquid nitrogen
  • Must be able to obtain gowning qualification to enter a cleanroom environment
  • May be required to work nights, weekends and holidays in a 10-hour shift structure.
  • Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.


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.

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.