Posted in

Quality Control Technical Services Manager – Bioscience

Quality Control Technical Services Manager – Bioscience

CompanySmithfield Foods
LocationCincinnati, OH, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s
Experience LevelSenior

Requirements

  • 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 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

Responsibilities

  • Responsible for qualification of testing equipment and validation/verification of quality control methods to ensure active pharmaceutical ingredient is 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; analytical method development, 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
  • Lead QC out-of-specification (OOS) investigations to determine product impact, root causes and identify corrective and preventive actions (CAPA) to prevent recurrence
  • Provide technical expertise to resolve equipment 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 to cGMP and Good Documentation Practices (GDP)
  • 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

Preferred Qualifications

    No preferred qualifications provided.