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Quality Assurance Specialist

Posted about 1 month ago

  • Expiry Date: 25 May 2022
  • Referral: 205843@accuick.com

Job description:

PURPOSE AND SCOPE OF POSITION:

  • Global biopharmaceutical company committed to improving the lives of patients worldwide. We seek to deliver truly innovative and life-changing treatments for our patients.

  • Our Vector CMO Quality Assurance team is responsible for overseeing and supporting external manufacturing operations of our global CMO partners.

  • The Specialist QA (CMO) position is an individual contributor role responsible for review of cGMP Controlled Documents such as SOPs, vector disposition, approval of batch records and management of implementation of required changes to meet cGMP and internal standards.

  • Position is considered remote by design.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
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, cell therapy manufacturing, or quality control is preferred.

  • Hands-on experience with material introduction and disposition is preferred.

  • Knowledge of cGMP regulations and FDA, EU, ICH guidance applicable to biologics and cell therapy manufacturing/quality control.

  • Strong computer skills with Word and Excel and other electronic manufacturing systems.

  • Detail oriented team player with effective planning, organization, and execution skills.

  • Extensive experience in Quality Assurance processes.

  • Good organization and time management skills.

  • Ability to work in a fast-paced team environment.

  • Strong written and verbal skills.

DUTIES AND RESPONSIBILITIES:

Key Responsibilities

  • Oversee and review CMO batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with supply chain, warehouse, and quality control departments.

  • Support the vector disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.

  • May Own, Review, and approve deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).

  • May Own, Revise, and Approve Standard operating Procedures as needed.

  • Lead small to large scope continuous improvement projects as assigned.

  • Participate in small and large cross functional project groups as QA Subject Matter Expert (SME), related to material introduction, dispositions, and master data approvals.

  • Other duties as assigned.

  • Knowledge, Skills, and Abilities

  • Knowledge of cGMP regulations and FDA, EU, ICH guidance applicable to biologics, cell therapy, and vector manufacturing/quality control.

  • Strong computer skills with Word and Excel and other electronic manufacturing systems.

  • Proven experience working on teams where combined contribution, collaboration, and results were expected.

  • Proven commitment to quality and continuous improvement.

  • 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.

  • Good organization and time management skills.

  • Ability to work in a fast-paced matrixed environment.

  • Strong written and verbal skills.

  • 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.

  • 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.