Associate III, Quality Assurance

Job Description

About This Role

The Quality Assurance Associate III is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The QA Associate III will perform all duties in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures, be proficient in their understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality Systems cross-functionally. Additional responsibilities include ensuring adherence to all regulatory licenses and regulations, review and approval of investigations, review/approval of GMP procedures, protocols and reports, support the development and performance of GxP Quality systems-related training, identify gaps in existing Quality systems and propose solutions to site management, participate in internal/external compliance audits, and prepare and analyze metrics for Quality compliance. Interfacing with key Quality, manufacturing, and PO&T customers, and coordination of investigations impacting the Quality areas. The QA Associate III will also support Quality Management for activities related to interviewing and training of employees, compliance with training policies, providing feedback for personnel development, and providing effective and timely decision making/corrective actions on the floor. The QA Associate III should be able to work effectively, independently and within a team framework, across all business areas and levels of the organization. This requires excellent written and verbal communication skills. The QA Associate III should have a mature leadership approach and understanding of their personal communication style and manage that effectively.

WhatYou’llDo
  • Review and approval of batch related documentation (cGMP procedures, Master Production Records, Solution Lot records, protocols, and reports) to support product disposition
  • Executes activities including; intermediate technical writing, advanced investigation support (root cause analysis/impact assessment), project representation (moderate or advanced complexity)
  • Supports resolution of both technical and compliance issues/gaps of moderate complexity. Aides in implementation of Quality Systems/System Improvements with some guidance, advanced technical problem solving (tools or enterprise systems) within function and across multiple functional areas
  • Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen
  • Supports and/or assists in GxP quality systems-related training. Provides some mentorship and training within and across functions

Who YouAre

The ideal candidate is detail oriented, eager to learn, seeks to understand and has knowledge of biologics manufacturing processes. Additionally, the candidate has excellent communication/collaboration skills, logical thinking, and can work across multiple levels of the organization.

Qualifications

Required Skills
  • Education and Experience: Education: BA/BS degree, Life Sciences discipline preferred witha minimum of 4 years of relevant industry experience
  • General understanding of relevant FDA/EMA regulations and ICH guidelines
  • Plans schedules and arranges own activities when accomplishing objectives.
  • Must be able to deal with ambiguity.
  • Understanding of the Quality role and concepts; able to practice and implement them
  • Ability to develop innovative/creative solutions to issues of moderate complexity.
  • Detail oriented aptitude.
  • Excellent oral and written communication skills




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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