Smithfield
Pharmaceutical
PharmaceuticalQCTechnicalServicesManager
Neural analysis suggests this role is
optimal for Mid candidates.
“Pharmaceutical QC Technical Services Manager at Smithfield. Skills: Quality Control, cGMP compliance, Team management, Technical services. Lead technical operations for quality control. Ensure compliance with SOPs and cGMP”
What You'll Achieve.
Ensure data integrity and compliance; Ensure active pharmaceutical ingredients are tested and manufactured in accordance with cGMP, SOPs, and safety requirements; Develop and meet QC compliance and safety goals; Ensure QC testing requirements are met; Ensure compliance with cGMP and Good Documentation Practices; Achieve company goals
Industry & Context.
Resolve equipment, software or testing issues; Support OOS investigations; Root cause analysis; Corrective and preventive actions
Relocation Package Available
What They're Looking For.
Must Have
Bachelor's degree from an accredited four-year college or university in a chemistry, microbiology or other technical field, 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, Demonstrated leadership skills, Ability to uphold regulatory, company, and customer standards, Proficient with complex mathematical calculations, Technical writing skills, Interpersonal skills, Communication skills (written and verbal), Ability to structure work plans, Ability to organize employees to achieve results, Demonstrated ability to manage multiple priorities in a fast-paced environment, Capable of working well with cross-functional teams in a dynamic setting, Works well in high pressure situations
What You'll Do.
Lead technical operations for quality control
Ensure compliance with SOPs and cGMP
Oversee qualification of testing equipment
Perform software validation of laboratory data systems
Manage QC software systems administration
Validate/verify quality control methods
Lead commissioning and qualification of equipment/software
Optimize analytical methods
Oversee method transfer and validation
Drive product lifecycle improvement projects
Champion cGMPs and safety
Respond to laboratory and safety issues
Support OOS investigations
Provide technical expertise for issue resolution
and review technical documents
Oversee software development lifecycle
Develop and maintain QC metrics
Develop and maintain business systems records
Manage employee performance
How You'll Work.
Team & Collaboration
Provide leadership for cross-functional teams; Work closely with Engineering/Maintenance; Work closely with Quality Assurance; Work closely with Manufacturing; Work closely with R&D teams; Interact with colleagues to ensure QC testing requirements are met; Work well with cross-functional teams
Communication Scope
Communication skills (written and verbal)
Process & Methodology
Lead and assign technical tasks/duties, Manage multiple priorities, Structure work plans, Organize employees to achieve results
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!** **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 wo
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