Documentation Specialist
Company: A-Line Staffing Solutions LLC
Location: Franklin Lakes
Posted on: June 26, 2025
|
|
|
Job Description:
Title: Quality Management Document Specialist III Pay Rate:
$34.20/hr Location: Franklin Lakes, NJ Note: This is a W2 contract
role, and it is NOT open to C2C or 3rd party candidates This
position is responsible for converting hundreds of documents from
one template to another, including minor content changes and
revising documents for reference updates due to an organizational
change separating one business unit into two. This position will
serve as primary support for the conversion of Quality System
Procedures and Records from the IDS business unit to the SM
business unit’s format and content, processing a high-volume of
Microsoft Word documents. The Quality Management Document
Specialist is accountable for support of the continued development,
improvement, and implementation of Quality Systems. This position
actively participates in quality guidance, product resolution
decisions, and project teams for process improvement and continuous
improvement activities. Job Responsibilities: · Apply quality
system standards to assigned quality system area · Develop
solutions to routine assigned activities of moderate scope &
complexity · Follow applicable company/unit procedures and make
updates to procedures and policies, as needed · Work within and
across functions for assigned quality systems · Maintain a working
knowledge of quality systems regulatory requirements and their
application to company/unit requirements · Serve as primary support
for the conversion of Quality System Procedures and Records from
IDS business unit to the SM business unit’s format and content ·
Perform other duties, as required Job Qualifications: · 5 years of
relevant experience, OR a combination of equivalent education and
relevant experience · High proficiency in Microsoft Word and
general documentation management · Ability to prepare or revise
policies, procedures, and revise documents with a high degree of
accuracy and efficiency · Working knowledge of FDA medical device
quality system regulations and international quality system
standards/regulations, such as 21 CFR Part 820, ISO 13485, MDSAP,
EU MDR/IVDR · Working knowledge of applicable corporate and/or unit
requirements · Ability to contribute to the completion of specific
programs and projects · Ability to ensure quality conduct of
projects, including design, data summary, interpretation, and
report generation for self and lower level project developers ·
Ability to determine and develop approach to solutions, working
independently within defined parameters and under minimal
supervision · Ability to develop solutions to routine assigned
activities of moderate scope and complexity · Experience with
Quality Systems, such as SAP, Trackwise, or PEGA, preferred · A
minimum of a Bachelor's Degree in Computer Science, Engineering or
a similar field; Certified Quality Auditor or Transactional Six
Sigma Green Belt Certification preferred
Keywords: A-Line Staffing Solutions LLC, Philadelphia , Documentation Specialist, Science, Research & Development , Franklin Lakes, Pennsylvania
