Documentation Specialist II, HSV Facility Operations & Engineering

Location
Huntsville, AL, United States
Posted
Jun 12, 2018
Ref
2-3303-925-2018
Required Education
High School or equivalent
Position Type
Full time
Position Summary:

In compliance with regulatory requirements, performs duties such as, but not limited to, word processing documents, input into CMMS, distributing documents to users, and maintaining the master documentation archive. Issues and archives documentation in equipment files for audit purpose. This job contributes to and supports the Maintenance Department.

Responsibilities:

Works under direct supervision performing tasks that are routine to semi-routine in nature. Updates entries in computerized maintenance management system and other databases. Review and close work orders, PM's/Calibrations complying with Industry and Government Standards. Scans, indexes, and archives master records. Performs “check-in” and “check-out” activities. Tracks internal/external distributions of controlled documents. Scan and attach IQ/OQ's, manuals, initial calculations, originals, etc. in the CMMS System. Maintains equipment files including EIF's processed in a timely fashion, issue equipment numbers, review form(s) for accuracy and compliance, input into CMMS and maintain throughout the equipment life cycle. Maintains the integrity of document formats. Provides assistance during client and regulatory audits. Maintains hardcopy master document files. Assist with receiving MRO items and other misc. storeroom activities. Assist with CMMS invoicing. Performs other duties as assigned.

Requirements:

A minimum of a High School diploma is required. An Associates degree is preferred. Equivalent experience may be accepted. A minimum of 2 years industry experience is required. Experience in a regulated environment such as FDA, GMP, QA or ISO Audit Documentation experience a must. Experience working in a GMP setting is preferred. Clear communication skills, both oral and written are required. Must be proficient in Microsoft Word and Excel. Experience using PowerPoint, CMMS and Quality Systems, a plus. Must be detail-oriented, dependable and flexible with strong organizational skills.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.