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Senior Specialist, Quality Assurance

Company: Bristol Myers Squibb
Location: Seattle
Posted on: March 18, 2023

Job Description:

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: Position Summary:The Quality Assurance Senior Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant. ---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 Senior 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. -Qualification Requirements:Education:Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required.------ -Experience:

  • 5-8 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.------ -
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.------ -
  • Strong computer skills with Word and Excel and other electronic manufacturing systems.------ -
  • Detail oriented team player with effective planning, organization, time-management, and execution skills.------ -
  • Proven experience working on teams where combined contribution, collaboration, and results were expected.------ -
  • Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.------ -
  • Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them.------ -
  • Extensive experience in Quality Assurance processes.------ -
  • Ability to work in a high paced team environment.------ -
  • Strong written and verbal skills.------ -Roles and 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.
    • Support GMP commissioning activities for the VVDT affected areas at Dexter, as needed
    • 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 resolution and compliance with current Good Manufacturing Practices (GMPs).------ -
    • Act as QA Subject Matter Expert (SME) and support cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.------ -
    • 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.------ -
    • Own department events and minor deviations--- -
    • May support internal and external audits, including documenting observations and oversee implementation of corresponding CAPAs (Corrective and Preventative Action). --- -
    • Perform quality review and approval of standard operating procedures ------ -
    • Writes and maintains the label and batch issuance procedures and participates in the development and deployment of document control tools for VVDT.
    • Issues production batch records to support VVDT operations.
    • Supports internal and external audits and regulatory inspections. This may require data gathering, interviewing, or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections.
    • Train and mentor junior associates.The starting compensation for this job is a range from $75,000 - $95,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our Eligibility for specific benefits listed in our careers site may vary based on the job and location.#LI-Onsite #BMSCARTAround 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. -Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. - Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. - This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visitto access our complete Equal Employment Opportunity statement.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Bristol Myers Squibb, Seattle , Senior Specialist, Quality Assurance, Other , Seattle, Washington

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