Kelly Services Quality Control Manager in Lawrence, Kansas
We are Kelly Science and Clinical , the second largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with a growing, global Healthcare contract manufacturer providing award winning services to and plays an essential part in many of the worlds’ most successful companies in the pharmaceutical, medical device and electronics industries.
Job Title: Quality Control Manager
Harnessing state-of-the-art technology and dedicated employees, our client has built a global reputation of exceeding customers’ expectations for over 35 years. Our client is immediately seeking a Quality Control Laboratory Manager who will be responsible for the development, optimization, trouble-shooting and technical transfer of routine and non-routine chemical and microbial assays and formulation transfers and will support process qualification. The QC Manager works independently and collectively as part of an integrated team environment with extensive interactions with Manufacturing, Maintenance, and Administrative departments.
Responsibilities may include (but are not limited to) the following:
Manages GMP laboratory activities for a pharmaceutical, (aseptic filling) CMO. Maintains quality service by enforcing organization standards and providing training guidance to team.
Support Pharmaceutical product platforms, including personnel management, project management, analytical method development, and validation.
Responsible for the development, optimization, trouble-shooting and technical transfer of routine and non-routine chemical and microbial assays and formulation transfers and will support process qualification.
Oversee site nonconformance investigations and associated CAPA, risk assessment, OOS investigations, and product release/disposition in coordination with the QRT Team.
Actively supports the quality and business requirements of the EMS and Quality Systems.
Actively reviews reports and documents for compliance to requirements.
Regulatory: Participates in communication with customers and prospective customers on product implementation and regulatory notifications related to product quality.
Maintains site compliance requirements for FDA and other relevant agencies.
Facility Maintenance: Provides oversight to direct reports performing this job role in support of laboratory equipment and assumes accountability for the work performed.
Maintains the calibration program and tracking for the site.
Purchasing: Uses the purchasing system to procure laboratory and validation supplies. CIMP System: Directly manages the continuous improvement and Kaizen events and projects.
Education/Experience Requirements/Skills :
Legally authorized to work in the job posting Country.
M.S./B.S. degree in Life Science/Science Major or equivalent
1O+ years laboratory management experience in a pharmaceutical facility,
10 years of direct GXP Quality Control experience, working knowledge of laboratory safety systems and chemical safety programs.
Experience in ISO standard execution.
Performance Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Process Improvement, Decision Making, Strategic Planning, Quality Management, and ISO implementation.
Generous Compensation and Benefits Package Including Relocation Assistance “EOE, including Disability/Vets”
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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)