Quality Assurance/Regulatory Affairs Documentation Specialist

Liberty, MO 64068 | Full Time Temp to Hire

Post Date: 06/21/2018 Industry: Warehouse Branch: Pay Rate: 14.50/hr

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

Duties & Responsibilities:
Performs QA document control function, including document login, tracking, processing, approval,
distributing, formatting, writing and archiving in compliance to internal and external requirements (21
CFR 820, ISO 13485:2016, etc.)
Coordinates the formatting, revision, review, and approval of SOPs and other GMP documents
including labeling.
Organizes and ensures accurate and reliable filing systems for the paper-based GMP documents.
May aid in the selection, evaluation and implementation of electronic document processing and
archiving systems, when needed.
Maintains and facilitates training program records including training matrix, training files, and annual
audit of training files.
Processes and provides timely and accurate update of stability studies, sterilization records, and
associated records.
Works with contract sterilizer to ensure steriliza on process.
Reviews quality outputs, change control, validation and qualification documents.
Maintains change control and deviation processes for SOPs, travelers, specifications, test methods.,
validation protocols/reports, technical protocols/reports, technical files, 510K documentation and other
GMP documents.
Assists in Quality investigations.
Generates Incident Reports, Change Controls and CAPA reports, including reviewing adequacy of root
cause, corrections, corrective, actions, preventative actions and effectiveness checks.
Updates and maintains any Quality Assurance/Document Control Logs and databases and generates
metrics as needed.
Assists in the preparation of data, reports and powerpoint presentations for the Management Review
meetings.
Par cipates in internal audits and suppor ng external audits
Any other du es as assigned by Direct Supervisor.

Jessica Drake


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