Document Control Specialist
Company: Kelly Services
Posted on: April 9, 2021
Kelly Services-- has been providing outstanding employment
opportunities to the most talented individuals in the marketplace.
We are proud to offer a long-term temporary opportunity to work as
a Document Control Specialist at a prestigious Fortune 500--
company working in Carlsbad.----Important information:--This
position is recruited for by a remote Kelly office, not your local
Kelly branch. To be considered for this position, you must use the
"Submit Resume" button to submit your resumes. If you have
questions about the position, you may contact the recruiter for
this position () however your resume must be received via the
"Submit Resume" button included within.--Job Title: Document
Control Specialist--Pay Rate: $29.25 per hour-- ----The role is
responsible for Document Control Management of a recently built
enzyme manufacturing facility serving pharmaceutical customers.
This operation is part of our Biosciences Division (BID), part of
our Life Sciences Solutions Group (LSG).BID is experiencing an
outstanding growth supporting exciting markets: Academia, Research,
Biotech, Pharma, Cell and Gene Therapy and Medical Devices.--How
will you make an impact?We are looking for a self-driven,
experienced and resourceful Document Control Specialist to support
with the buildout of our document control system, ensuring
compliance to all applicable standards.--What will you
- Day-to-day support of the document control workflow, which is
the vehicle to execute the request for changes within an ISO 9001
and Pharmaceutical GMP Quality Management System.
- Support the coordination, preparation and implementation of
controlled documents via Document Change Orders (DCOs) and
Engineering Change Requests (ECRs).
- Review and edit product documentation for consistency in
content. Interact with appropriate departments/sites to resolves
- Assist with global document review boards ensuring that
document changes which impact multiple sites are appropriately
updated congruently to prevent process drift.
- Drive continuous improvement of Document Control process by
employing Practical Process Improvement concepts, managing metrics,
reporting and communicating internally to Leaders and diverse
- Determine required approvers and route corresponding DCO/ECR in
Agile. On completion of change, ensure manufacturing documentation
is available at the point of use. Provide notification to
appropriate departments, where applicable.
- Prepare physical binder of Quality Management System (QMS)
documents for audit support.
- Train staff to document control processes, Good Documentation
Practices (GDP), etc.
- Compile master data for entry into Agile document management
- Transfer documents to new approved templates
- Perform other duties and cross training, as assigned--Education
- Associate degree from accredited college/university or
equivalent experience. Bachelor's degree in Science, Engineering,
Biochemistry, Biotechnology, Biology, or Biomedical Engineering
- Requires a minimum of 2-3 years relevant experience in a
regulated document control environment.
- Strong working knowledge of computer applications and current
software (Microsoft Excel, Outlook, Word, Project and PLM/ERP
system).--Knowledge, Skills, Abilities
- Experience with Agile and MasterControl electronic document
control systems preferred.
- Works independently on new and on-going assignments.
- Identifies and solves problems using established business rules
- Detail oriented and accurate.
- Strong verbal and written communication skills.
- Continuous improvement minded.
- Knowledge of quality standards (e.g., 21 CFR Part 820, ISO
9001, ISO 13485, MDSAP, excipient manufacturing regulations) and 21
CFR part 210/211, ICH Q7 and Eudralex volume 4 experience
preferred.----We invite you to bookmark our Web site and encourage
you to review it regularly for new opportunities worldwide: .Kelly
Services-- is a U.S.-based Fortune 500 company. With our global
network of branch locations, we are uniquely positioned to provide
our customers with international staffing support and our employees
with diverse assignments around the world.Kelly Services is an
Equal Opportunity Employer----Why Kelly--?Kelly Science & Clinical
is your connection to premier scientific and clinical companies
looking to hire talented people just like you. Every day, we match
science professionals with dream jobs that fit their skills and
interests-it's the way we think job searching should be. Nearly 100
percent of our science recruiters have a professional
background/education in science, so we know a thing or two about
the science market and how to get you noticed.About Kelly--At
Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world. Kelly is
an equal opportunity employer committed to employing a diverse
workforce, including, but not limited to, minorities, females,
individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
Keywords: Kelly Services, San Diego , Document Control Specialist, Other , Bonsall, California
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