Sr. Quality Specialist, Raw Material (v011)

  • Contract Duration: 12 months, possible extension and/or conversion to FTE
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is looking to hire a Sr. Quality Specialist, Raw Materials for a contract position with one of our global pharmaceutical clients. This is a one- year contract with possible extension and/or conversion to FTE. Experience with Oracle is a MUST!

POSITION SUMMARY

The Sr. Quality Specialist, Raw Material is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Specialist, Raw Material will be responsible for the day-to-day oversight and release of the incoming raw materials to support manufacturing operations and quality assurance for clinical and commercial drug product manufacturing activities. The Sr. Quality Specialist, Raw Material responsibilities includes, but is not limited to, stablishing inspection, testing and release requirements and participate in the vendor qualification activities.

KEY RESPONSIBILITIES of a Sr. Quality Specialist, Raw Material:

  • As part of the Company GMP Operational Quality group primarily responsible with providing quality oversight and support to Company Cell and Gene Therapy operations in the following key areas/activities to support of manufacturing operations across all phases of development and commercial such materials management and raw material analytical results
  • Responsible for GMP release of incoming raw material and components per approved specifications.
  • Review incoming materials against specifications and submit samples to QC Labs (internal and external) for testing
  • Review and approval analytical protocols/reports, OOS results, re-test plans, etc., and associated corrective and preventive action plans
  • Responsible for approval of COAs when applicable
  • Experience with vendor qualifications, setting raw material specifications, managing timelines
  • Support of the raw material retains program
  • Support new raw material risk assessments that will consider supplier information, general industry knowledge, and technical evaluations based on process and material knowledge with a focus on suitability of each material for its intended use in the process
  • Generate metrics for routine visibility and trending
  • Support Company QA in regulatory submissions and inspections
  • Communicate to material managements, QA and manufacturing of any OOS results that may impact release timelines
  • Review documentations generated by QC for accuracy and GDP per Company procedures
  • Support non-conformance (OOT/OOS) investigations, CAPAs, risk assessments, change controls associated to in-house testing

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES of a Sr. Quality Specialist, Raw Material:

  • Strong leadership skills with the ability to thrive in a high throughput environment
  • Cross- functional collaborator
  • Results Driven
  • Familiar with Oracle Systems
  • Ability to independently lead cross-functional teams and represent the Quality unit
  • Ability to communicate effectively across all organizational levels
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Attention to detail
  • Proven experience in Raw Material release and vendor qualifications program
  • Approving Technical Document Specifications to support the release activities
  • Familiar with Oracle Process manufacturing (OPM) system

REQUIRED EDUCATION AND EXPERIENCE of a Sr. Quality Specialist, Raw Material:

  • BS degree required, in the biological or chemical sciences preferred.
  • Minimum of 5 years of QA or QC, raw material release or inspection experience in a regulated Bio/Pharmaceutical industry with biopharmaceutical products, or biologics required.
  • Demonstrated strong working knowledge of GMP manufacturing.
  • Demonstrated broad working knowledge and experience of regulatory guidance and industry best practice quality control.
  • Experience in leading and supporting investigations and making decisions around issues that arise during data package review.
  • Experience working with oracle systems (OPM)
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– The Lenox Executive Search Team