Associate Quality Assurance Manager - BioScience

Reposted 5 Days Ago
Be an Early Applicant
Cincinnati, OH
In-Office
Junior
Food
The Role
The Associate QA Manager oversees quality systems compliance, drives adherence to cGMP, manages audits, and develops training programs.
Summary Generated by Built In

If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub.

A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We’re looking for motivated people who want to join our team and grow lasting and meaningful careers with us. 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.

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.

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 Systems & Regulatory Compliance

  • 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.

Audit & Inspection Readiness

  • 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.

Cross-Functional Collaboration & Investigations

  • 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.

Training, Leadership & Communication

  • 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.

Product Integrity & Release

  • Inspect finished products, packaging, and labeling for conformance before release and dispatch, ensuring every shipment meets the Company’s high standards.

Key Skills & Competencies

  • Meticulous attention to detail with a proactive approach to resolving quality challenges.

  • Exceptional written and verbal communication skills for clear documentation and team collaboration.

  • Proficiency with quality management systems (QMS) and electronic document control tools.

  • Strong analytical thinking and problem-solving abilities to support decision-making in a fast-paced environment.

  • Adaptable team player with the ability to manage multiple priorities while maintaining compliance.

WHAT WE’RE SEEKING:

To 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 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.

Relocation Package Available No

EEO 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 law.

If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.

Top Skills

Cgmp
Fda Regulations
Iso 22442
Mastercontrol
Trackwise
Veeva Vault
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The Company
HQ: Smithfield, VA
6,582 Employees
Year Founded: 1936

What We Do

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.

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