Consulting positions available with Malcom Associates are listed below.
The position of Senior Management Consultant – Life Sciences works with clients to manage, review, analyze, and critique Quality Systems for the purpose of streamlining, simplifying, and/or designing improvements to the Quality System documentation, data integrity, work flow, and processes in accordance with all applicable regulations (i.e. FDA/GXP, DEA, EMEA, ISO, etc.), industry standards, and client requirements.
The Senior Management Consultant must possess the following skills and qualities:
Working knowledge of the regulations (FDA/GXP, ISO, etc.) that pertain to Life Science Quality System documentation, work flow, and manufacturing processes.
Working knowledge of associated procedures and practices pertaining to Life Science Manufacturing, Quality Systems, and Documentation Systems (e.g., CAPA, Batch Records, Standard Operating Procedures, Laboratory Testing Procedures/Methods, Work Instructions, and/or other Quality System supporting documentation).
A demonstrated ability to review, analyze, streamline and otherwise improve Life Science
Quality System documentation, data integrity, work flow, and processes per the associated regulation.
Excellent written, oral, communication, and presentation skills; including the ability to prepare and present Life Science technical information and documentation to both technical and non-technical audiences.
Excellent interpersonal, leadership, communication, and managerial skills, coupled with the ability to work with minimum supervision.