CAPA Consultant

Piper Companies   •  

West Chester, PA

Industry: Staffing

  •  

Less than 5 years

Posted 62 days ago

This job is no longer available.

JOB DESCRIPTION

Piper Companies is currently looking for a CAPA Consultant in West Chester, PA to join an innovative player in the orthopedic industry to assist with quality initiatives for suppliers in manufacturing sites and raw material suppliers engaged in production of manufactured goods.

This is a consulting opportunity scoped to be about 12 months with potential for extension. The consultant will be supporting 2 specific CAPAs to bring them to close.

Responsibilities of the CAPA Consultant include:

  • Manage CAPAs and writing conclusions within compliance
  • Collaborate with suppliers and ensure CAPAs are in place
  • Assist with supplier files; Currently ~750 supplier files
  • Gap assessments, close the gaps in supplier files
  • Provide quality support to suppliers including audits/assessments, inspection technique support, validation activities, CAPA, and change controls management

Qualifications for the CAPA Consultant:

  • 3+ years of cGMP/ISO pharmaceutical/medical device industry experience
  • Working knowledge of medical devices and manufacturing process
  • Hands on CAPA experience and working with suppliers
  • FDR CFR Part 82/ISO 13485
  • Bachelor's Degree in Engineering, Life Sciences, or related field required; Six Sigma/ASQ Certification is a plus

Compensation for the CAPA Consultant position includes:

  • Commensurate to experience; $40-$55/hour contract rate
  • Consultant may receive PTO/Holiday pay
  • Full Benefits: Healthcare, Dental, VSP Vision, 401k option


Salary

$83K - $114K