Maynard
​Consulting Co.​
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.
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Quality Engineer - Arkansas
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Develop, author and maintain protocols for qualification, validation, re-certification and preventative maintenance of primary/ secondary process equipment, utilities and processes.
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General oversight of CAPA program, documentation and CAPA implementation
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Review and approval of annual product review.
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Review and approval of environmental trending data.
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General oversight of batch record generation, revision, issuance and review
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Compliance to cGMP regulations applicable to 503(b) Outsourcing Facilities requirements
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Compliance to SOPs and quality systems
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Author, revise and train on SOPs, protocols and reports
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Participate and contribute to the controlled document, change control, deviation, complaints and investigation quality systems
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Ensure processes and products are appropriately validated
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Monitor that equipment PM’s and calibrations are completed within required timeframes
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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)