Director of QC Analytical
Company: Kelly Services
Posted on: April 9, 2021
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
- 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
- Design and implement methods to increase efficiencies and
- Design and implement methods to improve knowledge of product
safety, purity, efficacy, potency, and stability.
- Design and implement strategies to transfer methods into QCA
- Ensure QCA decisions align with Quality System, GMP and
- Provide budgets for current and future operations including
strategy and plans for laboratory relocations and new laboratory
- 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
- Extensive experience with assay qualification and validation
- 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
- 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
- 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
- Ability to analyze and interpret complex, scientific
- 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
Keywords: Kelly Services, Los Angeles , Director of QC Analytical, Executive , Tarzana, California
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