Document Control Specialist
Company: Bell International Laboratories, Inc
Location: Saint Paul
Posted on: August 4, 2022
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Job Description:
Position Summary: The Quality Assurance Document Control
Specialist is a quality focused individual who ensures
documentation and record keeping processes conform to cGMP and
regulatory requirements as well as Bell International Laboratories
approved procedures and output documents are accurate. The
individual will assist in the day to day record management
activities within Bell Labs complying with company and regulatory
requirements.Responsibilities Perform QA document control
functions, including document login, tracking, processing, review,
distribution, release and archiving of documents.Coordinate the
revision, review, and approval and obsoleting of SOPs and other GMP
documents. Responsible for ensuring area managers perform annual
review of all cGMP documents and SOPs.Confer with document
originators to resolve discrepancies and compiles required changes
to documentsOrganize and ensure accurate and reliable filing
systems for GMP documents.Create and maintain Certificates of
Analysis' for customersMaintain in house training programs
including training matrix, training files and annual audit of
training files.Maintain key aspects of the quality system such as:
IQOQ, document control, CAPA, Change Control, Deviations, OOS's,
Annual Product Review, and othersActively participate in internal
audits, customer audits and other activities as assigned by
manager.Required Skills/Abilities Knowledge of laboratory equipment
set-up and operation, common laboratory techniques and safe
chemical handling Proficient at reviewing and editing
documentationFamiliar with cGMP's and the ability to follow
standard operation proceduresExcellent written, verbal and
interpersonal communication skillsStrong critical thinking and
problem-solving skillsAbility to prioritize multiple
responsibilities and manage deadlines accordingly. Communicate
effectively with all members of organization and all levels of
managementExceptional attention to detail and high level of
accuracy & organizationAbility to work independently with minimal
supervision in a fast-paced environmentAbility to adapt quickly to
changing policies and proceduresExhibit a quality mindset and a
willingness to develop yourself and others.Proficient with
Microsoft Office and Adobe AcrobatRequirementsRequired Education
and Experience Associates degree in scientific discipline2-5 years
of hands on experience with document management in a regulated
industry-pharmaceutical or medical device industry-with direct
document control experience.Preferred Education and Experience
Bachelor's degree in scientific discipline Audit or inspection
experienceDemonstrated knowledge of cGMP's, 21 CFR 210 and 211 and
other regulatory agency requirements sufficient to apply to quality
operations and compliance.
Keywords: Bell International Laboratories, Inc, St. Paul , Document Control Specialist, Other , Saint Paul, Minnesota
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