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Senior Quality Assurance Specialist (cGMP - Pharmaceutical) JD817688

JD817688

DPS is looking for a Senior Quality Assurance Specialist to work with a BioPharma client in the MA and NH areas. Ideal candidates should have a strong understanding of GMPs and have previous experience working within highly regulated pharmaceutical/biotech facilities. The QA Specialist will support the delivery of quality system activities at the Manufacturing Facility to ensure commercial and/or clinical products are manufactured and distributed in accordance with all regulatory and corporate requirements.

Category:
Quality
Location:
Massachusetts
Years of Experience Req.:
7+
Date Posted:
31/05/2019
Days Remaining:
29
Employment Type:
Full-time
Education Level Req.:
Bachelors Preferred

Senior Quality Assurance Specialist (cGMP - Pharmaceutical)            JD817688

MA, RI and NH areas

 

Summary:

 

DPS is looking for Senior Quality Assurance Specialists to work with BioPharma clients in the MA, RI and NH areas. Ideal candidates should have a strong understanding of GMPs and have previous experience working within highly regulated pharmaceutical/biotech facilities.

 

The QA Specialist will support the delivery of quality system activities at the Manufacturing Facility to ensure commercial and/or clinical products are manufactured and distributed in accordance with all regulatory and corporate requirements.

 

Responsibilities:

  • Responsible for being a quality contact and primary Subject Matter Expert (SME) for complex deviations for systems, processes and equipment related to engineering, facilities, automation, manufacturing and validation.
  • Supports and reviews complex deviation investigations related to manufacturing process equipment, utilities, automation, validation, and engineering.
  • Acts as an advisor and makes recommendation to Quality Assurance Management for the release of equipment based on completion of corrective actions related to a complex deviation.
  • Works closely with Operations, Facilities, Manufacturing, Automation, Validation, and Engineering to resolve open issues resulting from equipment failures, issues and deviation record reviews.
  • Leads the QA review and assessments of deviations; includes performing risk assessments, leading root cause analysis investigations, tracking, follow up, close out and reporting/trending.
  • Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
  • Leads the identification and implementation of improvement opportunities for issues related to automation issues, equipment and validation failures.
  • Working with all departments to guide the timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations.
  • Proficient in entering information from deviations into TrackWise and generating reports from these systems.
  • Provides QA oversight to equipment lifecycle activities including commissioning, qualifications and preventive maintenance.
  • QA review and approval of engineering drawings/documentation, specifications, system assessments, validation protocols, and validation summary reports.

 

Qualifications:

  • B.S. degree in Engineering, Chemistry, Biology or related field.
  • Knowledge of Six Sigma methodologies (e.g. Lean, 5S, Kaiz348987.262193en) and Critical Thinking methodologies (e.g. Kepner Tregoe).    
  • 5+ years’ of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities.
  • Thorough knowledge of cGMP/GDP and international regulatory requirements.
  • Operations experience in a GMP environment.
  • Ability to prioritiz348987.262193e daily activities in order to meet internal and external customer needs in a fast-paced environment.
  • Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors.
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