| |
Job Description |
Job Title: Documentation Specialist
Duration: 3+ Months
Location: Allston, MA
Duties:
The Manufacturing Document Specialist uses knowledge of compliance and good document practices to manage all process related documents within upstream operations.
Responsibilities include:
Works with document owner to prepare format and review text for technical content creation or change.
Interview staff engaged in process operations to create or revise documentation.
Prepares all associated written and electronic materials such as forms in accordance with site, company and global good documentation practice regulations
Works independently managing/processing large volume of documents under minimal supervision and direction while managing multiple priorities.
Displaying knowledge in cell culture, bioreactor and capture operations
Utilizing process knowledge to update procedures and training material.
Participating in cross-functional teams to effect change
Effectively demonstrates an understanding of cGMPs & how it applies to specific responsibilities.
Represents the organization at meetings such as MDI and project meetings.
Familiarity with deviation and CAPA management systems as it pertains to document changes.
Utilize document processing and manufacturing knowledge to improve process operations and affect positive change.
Works independently with minimal supervision and direction.
Participates in determining objectives of assignment.
Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business need
Skills:
Solid Experience and knowledge of document management disciplines.
Experience with formatting document and processing redline.
Experienced authoring and reviewing standard operating procedures, training material, and other controlled documents
Familiarity with deviation management
systems (i.e. Trackwise).
SPECIAL WORKING CONDITIONS: N/A
Ability to gown and gain entry to manufacturing areas
Education:
Bachelor's or Associate's Degree with 1-2 years in cGMP manufacturing environment
Experience with Good documentation practices and other applicable regulatory requirements.
Knowledge in editing controlled documents and Document Changes Requests (DCRs)
Contact: Arun Kumar
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@makrotech.com We shall be happy to help you.
|