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.

 

Key Qualifications:

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)

 

            1-800-549-0815                 ext. 1

           
 

 

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