Associate Quality Assurance Manager - BioScience

Smithfield Foods•Cincinnati, OH

About The Position

We are seeking a dedicated Associate QA Manager to join our team. In this pivotal role, you’ll be at the forefront of safeguarding the quality and integrity of our FDA-registered facility and the products we deliver. Your mission? To champion the enforcement of current Good Manufacturing Practices (cGMP) and uphold rigorous compliance standards across our quality management systems. You'll play a critical role in maintaining and enhancing our system controls and procedures, ensuring alignment with regulatory frameworks including 21 CFR Parts 210/211, ICH Q7, ISO 22442, and relevant EU guidelines. This is more than just a compliance role—it's an opportunity to be a key driver in the continual improvement of our processes and a guardian of the trust our customers place in every product we produce.

Requirements

Bachelor’s degree from an accredited college or university in science or related field and 2+ years of relevant experience; or equivalent combination of education and experience, required.
Knowledge and understanding of quality management systems, quality assurance principles, statistical process control, preferred.
Experience with quality systems such as deviation management, CAPAs, and change controls, preferred.
Proficient in electronic quality management systems, document management systems and training management systems, such as TrackWise, Veeva Vault, or MasterControl.
Experience in good record keeping / documentation practices.
Excellent writing, interpersonal and communication skills (written and verbal).
Knowledge of cGMP, including 21 CFR 210 and 211, ICH Q7.
Preferred knowledge of EU guidelines and ISO 22442.
Prior experience supporting regulatory inspections or audits.
Must have the ability to complete required applicable forms in English, which requires the ability to read and write in English.
Must be highly organized and detail oriented.
Ability to work well with others in fast paced, dynamic environment.
Must be able to meet tight deadlines and work in a timely manner.
Ability to be respectful, approachable and team oriented while building strong working relationships and a positive work environment.

Nice To Haves

Knowledge and understanding of quality management systems, quality assurance principles, statistical process control, preferred.
Experience with quality systems such as deviation management, CAPAs, and change controls, preferred.
Preferred knowledge of EU guidelines and ISO 22442.

Responsibilities

Drive and enhance cGMP compliance by preparing, implementing, and maintaining Standard Operating Procedures (SOPs) aligned with evolving regulatory expectations.
Stay ahead of current FDA, EU, and international regulatory trends to ensure ongoing facility and product compliance.
Lead the preparation and dissemination of validation protocols and reports to support product and process qualification efforts.
Maintain and monitor change control systems, ensuring timely and accurate updates to quality documentation and processes.
Conduct routine quality checks during manufacturing to verify alignment with established specifications and standards.
Assist in hosting and preparing for internal, supplier, customer, and regulatory audits.
Participate in on-site quality audits and support customer correspondence as part of audit preparedness and follow-up.
Monitor and safeguard quality assurance records, laboratory notebooks, worksheets, and production documentation to support traceability and audit readiness.
Collaborate closely with QA, laboratory, and production leaders to drive compliance and resolve quality issues.
Work cross-functionally on deviation investigations and take part in the review and approval of investigations, CAPAs, verifications/validations, and change controls.
Contribute to the development of new laboratory methods and support laboratory investigations to continuously improve testing accuracy and reliability.
Mentor and guide QA Associates, Specialists, and other team members on regulatory expectations, SOPs, and quality best practices.
Develop and deliver tailored training programs to elevate quality standards across departments.
Communicate effectively across teams to reinforce a culture of quality and regulatory excellence.
Inspect finished products, packaging, and labeling for conformance before release and dispatch, ensuring every shipment meets the Company’s high standards.