Deviation Writer/ Investigators
MCC needs experience Deviation writers and Investigators in the drug manufacturing industry. We have a number of projects open for these professionals in Arkansas, Colorado, and Illinois.
The ideal candidates will have experience writing Deviations and conducting investigations for pharmaceutical manufacturers.
SOP writing a plus.
Quality Engineer - Arkansas
Develop, author and maintain protocols for qualification, validation, re-certification and preventative maintenance of primary/ secondary process equipment, utilities and processes.
General oversight of CAPA program, documentation and CAPA implementation
Review and approval of annual product review.
Review and approval of environmental trending data.
General oversight of batch record generation, revision, issuance and review
Compliance to cGMP regulations applicable to 503(b) Outsourcing Facilities requirements
Compliance to SOPs and quality systems
Author, revise and train on SOPs, protocols and reports
Participate and contribute to the controlled document, change control, deviation, complaints and investigation quality systems
Ensure processes and products are appropriately validated
Monitor that equipment PM’s and calibrations are completed within required timeframes
Support the company functions involved in cGMP activities to build a culture based on problem solving
Pocess/Quality Engineering Consultant - Florida
Process/Quality Engineering Consultant is needed to support their Product Development team with a technology transfer, as well as a backlog of Nonconformances and CAPAs.
The Process Development Engineer will be responsible support the client with process development and a technology transfer (R&D to Manufacturing). This consultant will aid the team in the development and updating (existing) of SOPs for biologics products.
The ideal candidate will have 7+ years of hands-on process engineering experience within a pharmaceutical or biologics (preferred) environment. This individual should also be experienced with leading products from a small scale development stage through manufacturing and commercialization.
7+ years of Process Development experience (Pharma or Biologics)
Strong Technical Writing skill (IQ/OQ/PQ)
Experience with technology transfers (R&D – MFG)
Process validation experience
Cleaning and Equipment commissioning and qualification experience
Remediation experience (CAPAs and NCRs)