Senior Quality Specialist (GMP)

Our client, a leading pharmaceutical company focused on discovering, developing, manufacturing, and commercializing therapeutic treatments is currently seeking a Senior Quality Specialist to join their GMP Operational team for a 6-month contract with the potential to extend. Working in a hybrid setting, this person will be responsible for quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.

Responsibilities:

  • Supports the principles and application of quality assurance and regulatory compliance
  • Supports change control assessments, implementation and closure
  • Identifies and facilitates continuous improvement efforts
  • Supports drafting and revising Quality Agreements between CMOs/Suppliers and company, as needed
  • Helps represents Quality department on cross-functional working teams, applying strong communication and collaboration skills.
  • Support continuous improvement projects

Salary: $40 – $45/hr

Qualifications:

  • BS Degree and 2+ years’ GMP QA experience (master batch records, executed batch records, deviations, change controls, quality agreements)
  • Expanded conceptual knowledge of cGMP’s in a pharmaceutical setting
  • Good communication skills (written and verbal) and the ability to exchange potentially complex information
  • Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
  • Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA

If you are interested in this position, please send your resume to apowell@daleyaa.com

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