Senior Quality Assurance Compliance Specialist

Lab Pros, Inc.

Quality Assurance

August 15, 2014

The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs, deviation/CAPA review. The position will provide floor support to production departments to include line clearance, in-process checks and assistance with investigations. The Compliance Specialist also performs audits as assigned and participates in customer and regulatory audits as part of the Audit Team. All activities are perfomed according to internal Quality System requirements, cGMP and ISO 13485 standards.  

Responsibilities

  • Review and approve supplemental logs,charts and other documents in support of cGMP operations
  • Review batch records and certificates of analysis for accuracy and completion prior to final release of product, deviation/CAPA review.
  • Maintain the Approved Supplier List including updating and reviewing performance of vendors
  • Perform line clearance and checks on the production floor; troubleshoot and investigate quality issues
  • Perform internal and external audits as assigned
  • Particpate in regulatory and customer audits as assigned
  • Assist in the maintenance and implementation of the Quality System
  • Participate in project teams and perform other related duties as assigned

Requirements

  • Bachelors Degree required, preferably in the life sciences
  • 6+ years industry experience and knowledge of GMP/ISO requirements
  • Experience auditing in a GMP/ISO environment
  • Requires proficiency in word processing, spreadsheets and databases
  • Ability to interact positively and professionally with customers
  • Good presentation and organization skills
  • Excellent written and verbal communication skills

Apply Now

« Back to list

StratAcuity


 

Fresenius Medical Care