QC Systems & Validation Leader (cGMP/FDA)

Smithfield Bioscience, Inc; Cincinnati (OH); On-site; USD 105,000 - 140,000; Full time

Benefits offered by this job

Relocation package

Job summary

Smithfield Foods, Inc. is seeking an experienced QC lead to manage the technical operations for quality control of our products, ensuring cGMP compliance and data integrity across laboratory systems.

The role reports to the Senior Manager of Quality Control and involves leading equipment qualification, software validation, and cross-functional collaboration with Engineering, QA, Manufacturing and R&D. You will champion GMPs, safety, and GDP, oversee the software development lifecycle for

Qualifications

• Bachelor’s degree in a chemistry, microbiology or related technical field.
• 5+ years of demonstrated experience in FDA cGMP in a QC laboratory.
• 2+ years of demonstrated experience in team management or project leadership.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Ability to work cross-functionally with Engineering, QA, Manufacturing, and R&D.

Responsibilities

• Qualification of testing equipment.
• Software validation of laboratory data systems to ensure data integrity and compliance with 21CFR Part 11 and EU Annex 11.
• System administration for QC software systems, including data backup.
• Validation/verification of QC methods to ensure API testing and manufacturing in accordance with cGMP, SOPs, and safety requirements.
• Lead commissioning and qualification of laboratory equipment and software validation; analytical method optimization, transfer and validation/verification; and product lifecycle improvement projects.
• Provide leadership for cross-functional teams, including training, coaching, and mentoring.
• Champion cGMPs, safety, and workplace activities and help develop and meet QC compliance and safety goals.
• Respond to observed laboratory or safety issues and take action as appropriate.
• Work closely with Engineering/Maintenance, Quality Assurance, Manufacturing and R&D teams.
• Support QC out-of-specification (OOS) investigations and CAPA to determine product impact, root causes and preventive actions.
• Provide technical expertise to resolve equipment, software or testing issues and interact with colleagues to ensure QC testing requirements are met.
• Draft, revise and review technical protocols, reports, SOPs, and worksheets, ensuring compliance with cGMP and GDP.
• Timely and compliant oversight of the software development lifecycle for validated systems.
• Ensure QC metrics and business systems records are properly developed and maintained.
• Counsel employees to promote their success and manage performance issues.

Skills

Team management

Project leadership

cGMP compliance

Written & verbal communication

Cross-functional collaboration

Problem solving under pressure

Education

Bachelor’s degree in chemistry, microbiology, or related field

Job description

Smithfield Foods, Inc. is seeking an experienced QC lead to manage the technical operations for quality control of our products, ensuring cGMP compliance and data integrity across laboratory systems.

The role reports to the Senior Manager of Quality Control and involves leading equipment qualification, software validation, and cross-functional collaboration with Engineering, QA, Manufacturing and R&D. You will champion GMPs, safety, and GDP, oversee the software development lifecycle for