Quality Assurance Project Manager-Bioscience
Job in
Cincinnati, Hamilton County, Ohio, 45201, USA
Listed on 2026-06-02
Listing for:
Smithfield Foods, Inc.
Full Time
position Listed on 2026-06-02
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist / Manager, Quality Engineering, Quality Control / Manager, Data Analyst
Job Description & How to Apply Below
Have a seat at our table. When you join Smithfield, you become part of something special - a company that's sustainably feeding people around the world, producing good food the right way with respect for our people, animals, communities and planet. With opportunities across locations and functions, a culture grounded in our Core Four values - gratitude, communication, respect and accountability - and a strong commitment to learning, collaboration, and innovation, Smithfield offers challenging and rewarding careers where you can grow, contribute and make a real impact.
Apply Now!
THE VALUE YOU'LL BRING:
The position summary states the general nature and purpose of the job. Overall accountabilities are defined in this section.
Step Into a High-Impact Role in Quality Assurance!
Ready to make a real difference in the world of pharmaceutical and medical device manufacturing? Smithfield Bio Science, Inc. (SBC) is seeking a quality-driven professional for a full-time role reporting to the Senior Quality Assurance Manager
-a position that sits at the heart of our mission to deliver products that meet the highest global standards.
As the Quality Assurance Projects Manager, you'll be on the front lines of enforcing current Good Manufacturing Practices (cGMP) and safeguarding the integrity of our quality management systems. You won't just be checking boxes-you'll be shaping the standards that ensure our FDA-registered facility operates with unmatched precision and compliance.
Your oversight will be critical to the manufacture of high-quality Active Pharmaceutical Ingredients (APIs) and medical device components, all in accordance with 21 CFR Parts 210/211, ICH Q7, ISO 22442, and EU regulatory guidelines. You'll own system controls, uphold procedural excellence, and be a key driver of continuous improvement and operational readiness.
If you're passionate about compliance, thrive in a fast-paced regulated environment, and are ready to lead with confidence-this is the opportunity for you.
WHAT YOU'LL DO:
The below 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.
Quality Assurance Projects Manager Leadership
* Ensure Site Quality Objectives are met and the Site remains in a state of compliance with all applicable regulations
* In supplying Quality oversight - the WHY as well as the HOW Quality is applied - is central to the role.
* Own the Stewardship of the Quality Culture within the QA Function as well as the Site. Promote the values of a Learning Organization.
* Oversee GMP documentation and systems (Trackwise) management.
* Manage the site GMP training program
* Oversee the Quality Engineering and CSV activities.
* Support site GMP supplier management activities.
Document Management and Trackwise
* Document Management:
Maintain the GMP library and document storage for the site.
* Trackwise:
Oversee the Fit for Purpose and Use of Trackwise by the site. Responsible for the site SME for Trackwise.
* Training:
Administer the site GMP training component. Ensure that training records are maintained in Trackwise and are retrievable.
* Training Plans:
Ensure that GMP training plans are in place / in use for all members at the site. Training plans are to be role specific.
Quality Engineering / CSV
* Quality Engineering:
Oversee all aspects of quality engineering - change controls, GMP systems (purified water, HVAC), system drawings, and process / equipment modifications.
* Maintenance:
Assure that calibration and PM programs are up to date and performing as designed. Ensure that appropriate maintenance system tracking tools are in place.
* Metrics:
Track / trending of critical process metrics and ancillary support metrics (ie: EM Heat Maps, purified water quality)
* Fit for
Purpose:
Ensure that the facilities are Fit for Purpose through quality engineering assessments. Determine annual recapitalization budgets and planned shutdowns.
* CSV:
Oversee the stewardship of computer system validation across the site including manufacturing and the QC Labs. See that periodic CSV assessments are completed.
* Inspection Readiness:
Support the site's actions for being Inspection Ready. Create action plans for areas and systems needing remediation. Assist in developing / executing the tracking mechanism for Inspection Readiness.
Supplier Management
* Process Ownership:
Provide direction for GMP supplier management as the process owner.
* Approved Supplier List:
Maintain the site's GMP approved supplier list for materials and services.
* Periodic Review of Suppliers:
Direct the annual review of supplier performance and stratification of suppliers based on criticality.
* Quality Agreements:
Track and report on status of…
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