Sr. Quality Engineering Specialist

Our client, a leading pharmaceutical company focused on discovering, developing, manufacturing, and commercializing therapeutic treatments is currently seeking a Sr. Quality Specialist, QA Engineering to join their team for a 6-month contract with the potential to extend. This person will be responsible for supporting and executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs and effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

Responsibilities:

  •  
  • Review and approval of qualification activities, and periodic assessments.
  • Provide quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications
  • Review and approval of trending programs (equipment, facility, utilities, etc.)
  • Support EM and UM programs and control programs
  • Provide support of facilities and engineering projects, including capital projects, annual plant shutdown, and various improvement projects as assigned
  • Provide QA support of Equipment and Facility change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Support collaboration with customers to ensure quality systems are monitored and established metrics are met
  • Responsible for biennial review and approval of department and cross-departmental processes for continuous improvement
  • Responsible for identifying risks and communicating gaps for GMP process/systems
  • Participate in inspection readiness activities and provide support during regulatory site inspections. Provide post inspection support to address any regulatory observations

Salary: $75 – $80/hr+

Qualifications:

  • B.S in scientific or allied health field (or equivalent degree) and 3+years of relevant work experience
  • Experience providing QA support and oversight of GMP manufacturing operations
  • Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of cGMP’s and associated CMC regulatory considerations
  • Experience with continuous manufacturing a plus
  • Experience with equipment, facilities, and utility system qualifications activities in a cGMP setting, including change controls
  • Experience with event investigations, Root Cause Analysis (RCA), and CAPA
  • Knowledge of ASTM E2500, CSV/GAMP, and other associated standards
  • Experience with Veeva and Nuvolo preferred

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

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