Sr. Quality Specialist, Batch Disposition (v327)

  • Contract Duration: 6++ months, Hybrid
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Job description

Lenox Executive Search is seeking to fill a contractual role for a of a Sr. Quality Specialist with one of our global pharmaceutical clients. This is a 6 month contract with likely extension based on performance. Experience with batch disposition, documentation review, deviation review and change control are all necessary.

Key Duties and Responsibilities of a Sr. Quality Specialist:

  • Supports for quality oversight of Company Cell and Gene Therapy manufacturing operations across all phases of development and commercial
  • Responsible for GMP batch disposition activities including review of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition
  • Support Cell & Genetic Program and Quality projects including Quality system, protocol and test data review and manufacturing process/SOP improvements
  • Support QA execution of process and OOS investigations, and associated CAPAs
  • Supports change control assessments, implementation, and closure
  • Participates and supports in compliance activities and help drive the closure of any observations by partnering with Company Compliance and Quality Assurance for CDMO and CTO activities. Escalate critical and major finding to Quality management related to GXP Operational areas
  • Supports drafting and revising Quality Agreements between CMOs/Suppliers and Company, as needed Communicates proactively with internal and external partners and management
  • Assists department mgmt. with monthly/quarterly Quality System data review metrics and reporting

Knowledge and Skills of a Sr. Quality Specialist:

  • Expanded conceptual knowledge of cGMP’s in a pharmaceutical setting
  • Demonstrated experience providing QA support and oversight of GMP manufacturing operation in Cell & Gene manufacturing
  • Helps represents Company Quality on cross-functional working teams, applying strong communication and collaboration skills
  • Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
  • Support continuous improvement projects Knowledge and Skills
  • Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA Education and Strong communication and influencing skills
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Proficiency in using Microsoft Office applications
  • Some experience with quality metrics, dashboards, analysis, and improvement programs
  • Some experience with network-based applications such as Oracle, Trackwise or Veeva
  • Basic knowledge of current industry trends and could use the latest technologies

Education and Experience of a Sr. Quality Specialist:

  • Bachelor’s degree in scientific or allied health field (or equivalent degree)
  • Typically requires 3-4 years of Quality Assurance experience, or the equivalent combination of education and experience

Job Type: Contract

Salary: $65.00 – $70.00 per hour

Schedule:

  • 8 hour shift
  • Monday to Friday

Experience:

  • Pharmaceutical QA: 5 years (Preferred)
  • batch disposition: 1 year (Preferred)
  • change control: 1 year (Preferred)
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