Quality Assurance

With Quality Engineers

All team members are trained in Quality at PSC. We focus on compliance, quality systems and methods, audits, and product and process control and design. Our Quality Engineers specialize in QA Oversight, Gap Analyses, Training Compliance and Support, Review and Approval of Validation Documents, CAPAs, Non-Conformance Reports, Quality Agreements, and the facilitation of project documentation. We have expertise in quality compliance, audit rights, regulatory inspections, regulatory documentation, staff training, change control, qualification, investigations, deviations, production, stability, and complaints for Operations, Engineering Services, and IT Services. Many of our Engineers are ASQ certified with the Quality Engineer Certification (CQE) and Quality Auditor Certification (CQA). PSC promotes Quality training and certifications and offers all employees with sponsored trainings and exams.

 

Our Quality Engineer’s Expertise:

  • Change Control
  • Assessment of Change Request (ACR)
  • Risk Management
  • Deviations and Non-Conformance
  • Investigation Reports
  • CAPA – root cause investigation and implementation of corrective & preventative actions
  • Quality Agreements
  • Customer Complaints Documentation
  • Stability Reports
  • Regulatory Inspections
  • Regulatory Documentation
  • Staff Training
  • Review and Approval of Validation Documents
  • Internal audits
  • External Audits:
    • Audits planned
    • Audits executed
    • Reports issued
    • Vendor audit responses
    • Audit close-outs
    • Audit Reports including different levels (Critical, Major, Minor or Observation).

Download Our Non-Conformance Investigation White Paper

What Our Clients are Saying

“During the past year, our company has been working with PSC on various activities within the development and implementation of a new medical device product. PSC offers high quality services, and we can say that we have always been satisfied by their work.”

“The skillsets that PSC provides in regulatory support helped us overcome a large obstacle in particular. The regulatory support that we had from PSC was very independent and if we had an issue, PSC consultants were willing to work cross-functionally to meet our needs. No micromanaging required. Great communication. Minimal supervision. I don’t think we would have been as successful without them. The expertise and the connections we’ve created with PSC are beyond our expectations. I’ve never had that relationship with a company like I’ve had with PSC. Just phenomenal! It made my life easier.”

“This is to certify that PSC Biotech® (PSC) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”

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