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Your Opportunity

This is a full-time position reporting to the Senior Manager of Quality Control. The position is one of leading the technical operations related to quality control of the Company’s products pursuant to Standard Operating Procedures (SOPs) and in compliance with current Good Manufacturing Practice (cGMP) as required by the U.S. Food and Drug Administration (FDA).

Responsibilities

• Responsible for qualification of testing equipment

• Software validation of laboratory data systems to ensure data integrity and compliance with 21CFR Part 11 and EU Annex 11 requirements as well as GAMP 5 guidelines.

• Responsible for system administration functions for QC software systems, including data backup.

• Validation/verification of quality control methods to ensure active pharmaceutical ingredients are tested and manufactured in accordance with cGMP, SOPs, and safety requirements. 

• Lead and assign technical tasks/duties associated with 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 any 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 as needed to determine product impact, root causes and identify corrective and preventive actions (CAPA) to prevent recurrence.

• 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, standard operating procedures, and worksheets, ensuring compliance with cGMP and Good Documentation Practices (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 employee performance issues as needed. 

The above 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.

Qualifications

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 four-year college or university in a chemistry, microbiology or other technical field and 5+ years of demonstrated experience in FDA cGMP compliance environment in a QC laboratory.

• 2+ years of demonstrated experience in team management/development or project leadership is required

• Demonstrated leadership skills and the ability to uphold regulatory, company, and customer standards.

• Proficient with complex mathematical calculations, technical writing, interpersonal and communication skills (written and verbal).

• Ability to structure work plans and organize employees to achieve results with demonstrated ability to manage multiple priorities in a fast-paced environment.

• Capable of working well with cross-functional teams in a dynamic setting to achieve company goals.

• Works well in high pressure situations.