Director of QC Analytical

Company: Kelly Services
Location: Glendale
Posted on: April 10, 2021

Job Description:

Job Title: Director QC AnalyticalLocation:--Culver City, CA--POSITION SUMMARY: Direct the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, compliance to applicable state, federal, and country-specific regulations including cGMPs and internal standards for manufacturing, materials, and finished products related to the COVID 19 vaccine program--ESSENTIAL FUNCTIONS:

• Ensure the complaint (in line with all relevant guidances), efficient operations of Quality Control Analytical by overseeing all laboratory testing (in house and outsourced In Process, Lot Release, and Stability).
• Develop, review and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation, and stability studies.
• Design and implement methods to increase efficiencies and productivity.
• Design and implement methods to improve knowledge of product safety, purity, efficacy, potency, and stability.
• Design and implement strategies to transfer methods into QCA groups
• Ensure QCA decisions align with Quality System, GMP and regulatory requirements.
• Provide budgets for current and future operations including strategy and plans for laboratory relocations and new laboratory implementation.
• Develop the Analytical Quality Control staff to perform at Phase-appropriate levels of compliance.
• Oversee the performance of designated staff.
• Responsibilities include interviewing, hiring, and training employees, planning, assigning, and directing work; appraising performance; rewarding and disciplining employees, addressing complaints, and resolving problems.--EDUCATION/EXPERIENCE:
  • Bachelor's degree in biology, chemistry, or other science-related fields; equivalent combination of education and experience. Master's level degree preferred.
  • Ten plus years related quality experience (or 8 with a Masters and 6 with a Ph.D.) including a minimum of eight years at the management level with experience in cGMP lab operations within the pharmaceutical industry.
  • Extensive experience with assay qualification and validation activities.
  • Experience with a start-up pharmaceutical company preferred.--REQUIRED COMPETENCIES - KNOWLEDGE, SKILLS & ABILITIES:
    • In-depth knowledge in analytical method development and validation, and statistical quality control.
    • In-depth knowledge of GMPs, SOPs, and pharmaceutical regulations.
    • Ability to use sound scientific judgment in the management of the facility and processes to prevent regulatory action.
    • Understanding of GMPs and an ability to interpret and enforce regulatory requirements.
    • Ability to communicate professionally, knowledgeably, and efficiently with a wide range of employees and with all internal and external customers, both in writing and verbally.
    • Ability to work with contractors and suppliers, ensuring compliance with company standards and contractor systems.
    • Ability to define problems, collect data, establish facts and draw valid conclusions.
    • Demonstrated track record in managing staff and establishing a clear, strategic direction.
    • Ability to develop leaders, teams, and groups, and appropriately staff the QC department to meet business needs.
    • Ability to build morale and group commitments to goals and objectives.
    • Ability to analyze and interpret complex, scientific documents.
    • Ability to multi-task and prioritize.
    • Excellent project management skills.
    • Strong problem-solving.
    • Strong computer skills--#TJP2021_SPEC Why Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

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