Document Control Administrator
Company: International Vitamin Corporation
Location: Greenville
Posted on: July 29, 2022
|
|
Job Description:
Overview:
The Document Control Administrator is responsible for maintaining
standard operating procedures (SOPs) /controlled documents systems
at the IVC -Anderson (AND), Dairy Drive (DDR / WDD) and Woodruff
Road (WOD), SC Facilities in accordance with division, corporate
and regulatory requirements. This position is responsible for
participating in regulatory and customer (internal / external
audits). The Document Control Administrator is also responsible for
the development and maintenance of batch records and the batch
record storage system at the IVC Facilities noted above. This
position is responsible for managing Quality Systems office
supplies orders and assisting the Sr. Manager, Quality Systems as
needed.
Responsibilities:
STRATEGIC--- Develops and maintains the company's SOP systems in
accordance with corporate and regulatory requirements; Reviews,
edits, and writes standard operating procedures (SOPs) --- Develops
and prepares SOPs using word processing, desktop publishing, and
graphic arts; Assist in the coordination of the distribution,
signature receipts, filing and archiving of new and revised SOPs---
Performs periodic audits of the SOPs for the purpose of identifying
areas of deficiencies; Ensures deficiencies are addressed; Assists
in regulatory and customer (internal / external) audits--- Develops
and maintains the procedure for the proper maintenance of batch
records for lots of codes produced and packaged at IVC - Woodruff
Road (WOD), Anderson (AND) and Dairy Drive (DDR)--- Reviews and
preserves all batch record documentation; Creates, updates, and
maintains the batch record retrieval program--- Maintains a system
for filing and archiving of company batch records at AND, WOD and
DDR.--- Scans batch records associated with production, packaging
and release of product to the Company's applicable Intranet
websiteTACTICAL--- Administers the review, approval, and revision
of procedures, specifications, and forms--- Works with initiators
to rewrite, clarify, or reconstruct controlled documents; Ensure
technical accuracy and traceability of all documentation---
Maintains a tracking system for all procedures / controlled
documents--- Interprets and follows the guidance of frequent policy
changes, and assessing the effects of changes on linked systems---
Participates and assists in self audits, internal / external
customer and external regulatory Quality Systems audits---
Integrates various sources of information into uniform style and
language regulatory compliance--- Assist in developing
documentation for instructional, descriptive, reference and/or
informational purposes--- Provides procedures / controlled
documents to internal and external customers; Assists in
maintaining an electronic SOP system for the facilities--- Oversees
the annual destruction of Batch Records / Controlled Documents and
maintains documentation of destruction--- Files, organizes and
stores SG gel mass batch records and Tablet / HSC premix batch
records--- Maintains the filing, organization and storage of
product batch records--- Provides batch record information to
internal and external customers--- Assists in ordering department
office supplies--- Any and all duties deemed necessary by the
Quality Systems Manager regarding the Quality Systems department -
-
Qualifications:
Minimum--- 3+ years document control or regulatory administration
experience--- 3+ years Quality experience in a cGMP regulated or
similar manufacturing environment - Preferred> 5 years Quality
and Document Control experience in a cGMP regulated manufacturing
facilityEducation--- High school diploma and three years document
control or regulatory administration experience may be substituted
for minimum educational requirementsPreferredTwo-year degree in
Science, English, Communications or related fieldQualifications---
Proficiency in Microsoft Office Suite (Outlook, MS Excel, MS Word,
PowerPoint preferred)--- Knowledge of Internet browser (i.e.,
Internet Explorer, where scanned batch records reside) ---
Knowledge of electronic database (i.e., MasterControl)---
Knowledgeable of cGMP / FDA regulatory requirements--- Exposure to
regulatory and customer audits--- Highly organized with strong
written and verbal communication skills--- Demonstrated
professional communication abilities--- Strong root cause analysis
and troubleshooting skills--- Ability to interact with various
departments and skill levels in a professional and consistent
manner
Keywords: International Vitamin Corporation, Greenville , Document Control Administrator, Other , Greenville, South Carolina
Click
here to apply!
|