Smithfield BioScience, Inc.
Bioscience
QualityAssuranceOperationsManager
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“Quality Assurance Operations Manager at Smithfield BioScience, Inc.. Skills: Quality Assurance, cGMP, Regulatory Compliance. Ensure all Site Quality Objectives are met. Maintain a state of compliance with all applicable regulations”
What You'll Achieve.
Ensure all Site Quality Objectives are met; Improve product quality and efficiency
Industry & Context.
Analytical Thinker – Brings logic, critical thinking, and data-driven decision-making to every challenge; Troubleshoot production issues
What They're Looking For.
Must Have
Bachelor's degree from an accredited four-year college or university in an engineering, chemistry, microbiology or other relevant technical field and 5+ years of relevant manufacturing experience, or an equivalent combination of education and experience, Minimum 2 years of demonstrated experience in team management/development or project leadership, In-depth knowledge of relevant regulations and standards in the pharmaceutical industry (e. g. , 21 CFR Part 210/211, ICH Q7, 21 CFR Part 11), understanding of Good Manufacturing Practices (GMP) and their application in the pharmaceutical industry, understanding of data integrity principles (ALCOA+), communication skills, analytical thinking, critical thinking, cross-functional collaboration skills
Nice to Have
Advanced experience in the API manufacturing, Certified Quality Manager (CQM), Certified Quality Auditor (CQA), Six Sigma Black Belt, Bilingual communication in Mandarin and English
What You'll Do.
Ensure all Site Quality Objectives are met
Maintain a state of compliance with all applicable regulations
Own the Stewardship of the Quality Culture
Oversee the review and approval of Manufacturing Batch Releases
Control the final release of Products to the Customer
Manage the oversight of Shop Floor Quality Assurance
Maintain all aspects of GMPs in manufacturing areas
Monitor all aspects of the Product Stability Program
Maintain facility in a constant state of readiness for inspections
Provide real-time quality oversight of manufacturing processes
Administer review of batch production records
Verify raw material status and equipment calibration
Verify prescribed GMP training has taken place
Administer the investigation process for all deviations
Oversee and approve completed batch records
training forms are organized
Maintain the master batch records
Maintain activities associated with environmental monitoring
Maintain all stability sampling
Troubleshoot production issues to maintain compliance
Oversee Quality by Design
Oversee and Improve process automation capabilities
Manage site capital Projects
Improve product quality and efficiency via SPC and Lean Six Sigma
How You'll Work.
Team & Collaboration
Cross-team collaboration
Communication Scope
Exceptional Communicator – written and verbal communication skills; Bilingual communication in Mandarin and English is advantageous
Process & Methodology
Project management experience, Manage site capital Projects
Full Job Description
**If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub.** 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 BioScience, 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 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 readi
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