Compliance Automation Specialist | Albany, NY

Detailed Information

  • Location: Albany, NY

  • Company: Perkinelmer

and maintains technical writing standards. Writes, modifies, and changes-controlled documents. Writes, reviews, and maintains department standard operating procedures. Edit, standardize, or make changes to materials prepared by other writers or personnel. Coordinates projects and documentation assignments.

Works on Change Controls in a regulated Gx P site Coordinates with Cross functional teams for sign offs on documents related to quality systems and Change Controls Manages and guides the completion of Change Controls under their purview Utilizes excellent communication skills to drive the completion of work Balances workload of changing priorities to deliver urgent documents in a timely

fashion Basic Qualification: Bachelor's Degree 5+ years of experience with bio medical equipment or manufacturing, particularly in Quality Review required Preferred Qualification: Experience with: Good documentation practices (GDP) FDA regulated environments Laboratory systems Nonconformance and deviation management Building consensus among subject matter experts Process mapping Harmonizing documentation across groups Document control including document management system Physical Demands: Must be able to remains in a stationary position more than 25% of the time The person in this position needs to occasionally move inside and outside labs Frequently operate on instruments, objects, tools or

controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.

Regularly move or lift up to 25 pounds and occasionally move or lift up to 100 pounds Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument), distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position. Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer PDN-9ad3c01b-bd36-40a2-b502-f6288965c07f

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