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Quality Specialist
Ref No.: 17-09914
Location: North Waltham, Massachusetts
Position Type:Direct Placement

Responsibilities:
  • Provide quality representation, guidance, leadership, and direction to product development teams for Biological and Chemical API and Drug Product.
  • Provide technical expertise for product quality decisions and project team decisions.
  • Interface with contract manufacturing organizations, oversight responsibilities include review of batch documentation, deviations, investigations, etc. up to and including product release.
  • Work closely with QA Associates, to mentor, guide and support daily product activities.
  • Provide back-up support to on-going QA operations as needed, e.g. review and approval of analytical methods validation and transfer activities.
  • Review of regulatory documentation and submissions.
  • Maintenance, management, and enhancement of quality systems to ensure they conform to company quality practices and international regulatory compliance requirements.
  • Assure product disposition procedures and policies provide safe, pure and efficacious products.
  • Lead and/or support investigations into variances and quality issues and are able to assure that proper changes are made to guarantee continued and consistent product quality.
  • Identify and evaluate fundamental quality, technical and product development issues and provide leadership, strategic input, guidance and direction for functional areas of the business and partnerships.
  • Provide QA support for Quality System cross-functional team development activities such as TrackWise enhancements for Change Control, Deviations, Investigations, and Supplier Quality Management. Support implementation of new software systems for continuous improvement of current paper based systems.
  • Participate in Quality Systems continuous improvement projects,
Qualifications
  • Ten to fifteen years of experience in the quality function.
  • Thorough knowledge of cGMP's and pharmaceutical manufacturing requirements
  • Experience in product development and expectations for early phase clinical trials
  • Working knowledge of FDA and EU requirements and guidance documents
  • Broad quality experience, including biologic and chemical drug manufacturing operations, API, and drug product release, method development, method validation and transfer, QP release, and process validation.
  • Ability to work well on a team and as an individual contributor.
  • Demonstrated leadership skills are critical to this role.
Education
  • Bachelor's, degree in a scientific discipline or related field