Senior Quality Assurance Inspector in Carlisle, PA at Pyramid Consulting, Inc

Date Posted: 7/11/2020

Job Snapshot

Job Description

Immediate need for a talented Senior Quality Assurance Inspector with experience in the Pharmaceutical Industry. This is a 12+ Months contract opportunity with long-term potential and is located in Carlisle, PA. Please review the job description below.
Job ID: 20-19857
Key Responsibilities:
  • Proficient in the production operations and quality procedures for the area(s) to facilitate compliance to regulations and to provide a good understanding of processes when conducting cGMP investigations.
  • Initiates, writes, reviews, edits, and drives investigations, interim reports, and commitments to closure to meet established timelines using the Trackwise/QTS system.
  • Assists and supports the manufacturing/packaging staff in detecting and solving compliance errors during manufacturing and packaging operations.
  • Participates in understanding failures (FMEA) and resulting CAPAs through investigations, root cause analysis, and incident reports.
  • Maintains proficiency in performance of all applicable Standard Operating Procedures (SOPs).
  • Authors and reviews SOPs, master batch records and other site technical documents.
  • Off shift and weekend availability sometimes required.
  • Other duties, responsibilities and qualifications may be required and/or assigned as necessary.
  • Bachelor's degree in a technical field (Biology, Chemistry, Engineering, or Pharmacy)
  • 4-6 years experience overall.
  • 1-2 years’ experience in conducting and documenting manufacturing incident or other types of investigations is required.
  • Training in Root Cause Analysis (method 1), CAPA, Human Performance (Client), and Technical Writing programs.
  • Familiarity with the use and functionality of Trackwise/QTS or similar enterprise system highly preferred.
Key Requirements and Technology Experience:
  • Experience in a manufacturing environment.
  • Strong verbal communication skills.
  • Demonstrated advanced technical writing skills.
  • Strong understanding of cGMP concepts and requirements.
  • Strong understanding of mathematics and statistics.
  • Able to demonstrate accuracy and thoroughness while completing work in a timely manner.
  • Investigations experience - offering manufacturing deviations experience/investigations
  • Experience in Quality System (TrackWise).
  • Green Belt/Black Belt certs are suitable.
  • MANDATORY: Root Cause Analysis + Writing Tech Reports.
Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.