Quality Assurance Document & Training Manager - BioScience
Company: Smithfield Foods
Posted on: September 17, 2023
Your OpportunityThis is a full-time position reporting to the
Director Quality Assurance. As a Quality Assurance Document and
Training Manager at Smithfield BioScience (SBC), your primary
responsibility will be to develop and maintain an effective quality
management system (QMS) for SBC Document Management and Control as
well as oversee the SBC Training system to ensure compliance with
pharmaceutical regulatory requirements and industry standards. You
will also oversee the QA review of cGMP documentation generated
during routine activities at the facility. Salary Range $78,500 -
$116,600 Core Responsibilities
Create, revise, and maintain company standard operating procedures
(SOPs) and other cGMP documents throughout the document lifecycle,
including initiation, revision, distribution, approval, and
Coordinate archiving of cGMP records and obsoletion of expired
records and documents.
Ensure controlled copies of SOPs are managed, updated and available
at designated points of use.
Maintain inventory of approved and effective Master Batch Records
and issue batch production records from approved Master
Maintain validation files (e.g., validation protocols, summary
Establish consistent and effective training curricula for SBC
personnel in consultation with department managers, ensuring
training is documented in accordance with regulatory
Develop training metrics to monitor compliance and effectiveness of
the SBC training system.
Serve as system owner for SBC's electronic systems for Document
Control (Trackwise DMS) and Training (Trackwise TMS).
Develop, implement, and maintain robust DMS and TMS quality systems
aligned with relevant regulations and standards for active
pharmaceutical ingredient (API) manufacture (e.g., 21 CFR Parts 210
and 211, ICH Q7, FDA Guidance documents).
Support customer audits and regulatory inspections with respect to
training records and/or document requests.
Oversee New Employee Orientation, including evaluation of the
program for effectiveness.
Coordinate the QA review of cGMP documentation generated at SBC,
including raw material receipt; product manufacture, release, and
dispatch; and other regulated activities associated with the
Stay informed of regulatory changes, industry best practices, and
technological advancements in the field, and update the DMS and TMS
Lead a team of QA Associates for these responsibilities at SBC.
Provide leadership for cross-functional teams, including training,
coaching, and mentoring.
Counsel employees to promote their success and manage employee
performance issues as needed
The above statements are intended to describe the general nature
and level of work being performed by people assigned to this job.
They are not intended to be an exhaustive list of all
responsibilities, duties, and skills required of personnel so
classified. May perform other duties as assigned. QualificationsTo
perform this job successfully, an individual must be able to
perform each essential duty satisfactorily. The requirements listed
below are representative of the knowledge, skill, and/or ability
required. Reasonable accommodations may be made to enable
individuals to perform the essential functions .
Bachelor's degree from an accredited four-year college or
university in a science or technical field and 5 years of relevant
experience performing Quality Documentation/Training duties in a
cGMP environment (pharmaceutical industry preferred); or an
equivalent combination of education and experience, required.
2 years of demonstrated experience in team management/development
or project leadership is required, preferably in a pharmaceutical
In-depth knowledge of relevant FDA regulations (e.g. 21 CFR Parts
210 and 211, 21 CFR Part 11, and ICH Q7)
Understanding of medical device regulations (e.g. ISO 13485, ISO
22442, 21 CFR Part 820) preferred.
Strong understanding of Good Manufacturing Practice (GMP) and its
application in the pharmaceutical industry.
Experience in developing, implementing, and maintaining quality
management systems, preferably in compliance with FDA
Familiarity and proficiency with the TrackWise DMS and TMS modules
for Document Management and Training is a plus.
Experience with Good Documentation Practice and ALCOA
Experience in developing and delivering training.
Strong technical writing skills and verbal communication skills,
with the ability to effectively interact with cross-functional
teams, regulatory authorities, and external stakeholders.
Strong computer skills including Microsoft Office and eQMS
Career BenefitsTo learn more about Smithfield's benefits, visit
smithfieldfoods.com/careerbenefits.Why Work at Smithfield Foods? We
are committed to meeting our employees' needs, addressing their
concerns and helping them enjoy rewarding careers with our company.
PEOPLE MATTERWith more than 60,000 jobs globally, our employees
drive our success. We strive to create a fair, ethical and
rewarding work environment.GROWTH & DEVELOPMENTWorking at
Smithfield isn't just a job - it's the foundation for a lifelong
career with training designed to help you advance
professionally.BENEFITSOur people matter. That's why we offer
excellent, comprehensive benefits packages to our full-time
employees.SUSTAINABILITY PLEDGESustainability is ingrained in our
culture and guides how we operate. We believe in innovating for the
future.About Smithfield Foods Headquartered in Smithfield, Va.
since 1936, Smithfield Foods, Inc. is an American food company with
agricultural roots and a global reach. With more than 60,000 jobs
globally, we are dedicated to producing "Good food. Responsibly--"
and serve as one of the world's leading vertically integrated
protein companies. We have pioneered sustainability standards for
more than two decades, including our industry-leading commitments
to become carbon negative in U.S. company-owned operations and
reduce GHG emissions 30 percent across our entire U.S. value chain
by 2030. We believe in the power of protein to end food insecurity
and have donated hundreds of millions of food servings to our
communities. Smithfield boasts a portfolio of high-quality iconic
brands, such as Smithfield -- , Eckrich -- and Nathan's Famous -- ,
among many others. For more information connect with us on
Facebook, Twitter, LinkedIn and Instagram. EEO/AA Information
Smithfield is an equal opportunity employer committed to workplace
diversity. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, national origin, age, gender identity, protected
veterans status, status as a disabled individual or any other
protected group status or non-job characteristic as directed by
Keywords: Smithfield Foods, Cincinnati , Quality Assurance Document & Training Manager - BioScience, Executive , Cincinnati, Ohio
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