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Job Description |
Job Title: Documentation Editor
Duration: 2+ Years
Location: Lake Forest, IL
Description:
Development, preparation and proofreading of documents related to new product development and existing drug products in cooperation with Research and Development, Engineering, Manufacturing, Quality, etc.
Document control and maintenance to existing document changes in methods, manufacturing processes and quality standards.
Maintain change management system in accordance with governing regulations and internal procedures.
This position is the primary contact for specification content, format and routing to subject matter experts for approval.
Principle source for resolving specification issues. Manage and implement strategic documentation projects.
Experience:
BS or equivalent: Engineering/Chemistry/Pharmacy/Biological Sciences; knowledge of analytical methods and manufacturing operations preferred; proficient in Quality document control procedrues, GMPs and regulatory requirements.
Good oral and written communication skills required as well as the ability to interface with all levels of management, supporting functions, plants and outside customers. Customer service oriented;
must be able to work under dealines and pressures.
Computer skills a must. Requires excellent project management skills and attention to detail.
This individual must possess the ability to manage multiple projects and priorities for multiple customers.
Responsible for compliant change control of documentation and labeling including new and revised procedures, department SOPs, manufacturing specifications and domestic labeling artwork.outside contract and third party manufactured product.
Responsibility includes day to day authority to develop, annotate, format, review and approve documentation and labeling.
This position is responsible for the timely approval and release of specifications and labeling artwork in accordance with project milestones and customer requirements under the direct supervision of the section manager.
Contact: Arun
The best telephone number to reach me is 973-481-0100 Ext:3171. I would appreciate if you forward your updated word formatted resume to arun.kumar@makrotech.com for review before we speak.
For any reason, you are not able to submit your resume or for any further information, please call our Candidate Help Desk at 973-679-5005.or E-mail your resume at recruiter@makrohealth.com We shall be happy to help you
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