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Documentation Specialist
Ref No.: 18-08015
Location: San Diego, California
This role will support the QA department in specific document control activities. Specifics of the job are as follows:
• Aid in writing, formatting and subsequent processing of documents (SOPs, MPs, RMS, Labeling) relating to the implementation of new products that are under design control.
• Write/update procedures by using a template/feedback provided by a subject matter experts
• Initiate required forms to process the documents through an electronic or paper based document management system.


• Communicate with extended team and vendors to ensure alignment of various document related information (Part Number, Descriptions, Bill of Material Data, CofC or CofA Data).

Preferred educational background:
Bachelor’s Degree in a biological science or engineering discipline or equivalent experience.

Preferred experience:
• 1-2 years of Document Control experience in an FDA regulated environment, preferably medical devices and/or in vitro diagnostics.
•.
• Experience with revision control.
• Experience in a GMP type environment (production, lab) preferred.
• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR.
• Experience with 21 CFR 820, ISO 13485.

Profile of qualified candidate:
• Knowledgeable of federal and other regulations, e.g. QSRs, ISO 13485, CMDR, etc.
• Demonstrates commitment to the development, implementation and effectiveness of Ameritech’s Quality Management System per ISO, FDA and other regulatory agencies.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
• Must be flexible and adapt to changes.
• Ability to multi task and set priorities independently.
• Must be organized and extremely detail oriented.
• Must be able work independently but comfortable interacting independently with various groups within the company.
• Must be motivated and willing to take on challenges.
• Takes initiative to problem solve and communicate with extended team members.
• Proficient in MS Word/Excel.
• Experience with Document Control databases such as Ensure, Agile, act.
• Strong communication skills.
• Ability to work in a fast paced environment.