Quality Assurance/Regulatory Affairs Documentation Specialist - Full-time

The position of Quality Assurance/Regulatory Affairs Documentation Specialist shall be responsible for
assisting in the implementation and maintenance of the Quality Management System (QMS) by
coordinating the revision, review and approval of Standard Operating Procedures (SOPs) and other Good
Manufacturing Procedures (GMP) documents ensuring compliance with applicable domestic standards
and regulations as well as ISO 13485:2016. The scope of activities includes, but is not limited to:
document control function, including document login, tracking, processing, distributing and archiving;
management of CAPA, change management, and non-conformance records; maintaining and facilitation
of stability studies and QMS metrics; participating in internal audits and supporting any external audits
and backup for Quality Assurance Technicians when necessary.

Starting Pay is 14.50/hour

Position is located in NKC,MO

Experience with electronic document control a plus.
QA/RA Document Control Specialist Job Description Rev 12/17
Strong written and verbal communication skills
Ability to understand and execute instruc ons.
Well-organized and detailed oriented.
Must be self-motivated with ability to handle, organize and prioritize multiple tasks and be able to
perform under pressure to meet deadlines.
Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the
issues/discrepancies in a diplomatic, flexible and constructive manner
Familiarity with general o ce so ware such as Word and Excel

Qualifications:
2-5 years of hands-on experience with document control processes in the biopharma, medical device
or medical industry.

Physical Requirements:
Able to move/li up to 25 lbs unassisted
Posi on spends 80% amount of me sitting or walking in a production environment
Ability to work over me when required of the position