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Quality Control Laboratory Supervisor
Greenville, NC 27834 United States
This position requires the ability to mentor and guide a team in the successful and timely execution of laboratory analyses, to interact with clients regarding their projects and products, as well as provide analytical laboratory support testing.
Key Responsibility Areas:
•Testing Support: Lead the planning, scheduling, and communication of all required laboratory analytical testing to ensure the highest levels of efficiency and quality standards are met with occasional testing within the laboratory to keep programs on tract.
•Exception Management: Initiate and perform investigations for out-of-specification and out of trend results as well as deviations from standard operating procedures. Ensure timely and comprehensive investigations in compliance with established internal procedures.
•Quality: Ensure the quality of work, products, and services as a priority; comply with or exceed all regulatory, cGMP compliance standards, and data integrity requirements as well as ensure accuracy of analyses as it relates to right first time measures.
•Safety: Ensure adherence to all workplace safety laws, regulations, standards, and practices and actively advances a culture of safety within their team and organization.
•People Development: Ensure the career growth development of direct reports by providing on-the-job training, mentoring and guidance.
•Process Improvement: Identify and recommend opportunities for improved efficiencies, customer service, and teamwork within the analytical group as well as monitor key performance indicators.
•Follow all regulatory guidelines, cGMP guideline, Environmental Health and Safety regulations as required by the job function
•Mentor and guides a team of 3-6 scientists and other laboratory personnel at various levels
•Develop, evaluate, validate, verify or otherwise qualify compendial and non-compendial methods and procedures for excipients, actives, finished products and packaging components
•Solve problems with methods, instruments, products or processes; interpret and trend data generated, escalate notification procedures as appropriate
•Perform comprehensive and structured investigations for out of specification results or deviations utilizing company procedures and established root cause analysis techniques
•Responsible for development and performance management of direct reports including training, coaching and mentoring
•Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Control and throughout facility
•Lead in the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards
•Author and review analytical procedures, validation documents, portions of regulatory submissions for site non-commercial and commercial projects relating to QC
•Schedule analytical work and review analytical data packets and analysis reports, as appropriate
•Ensures all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules
•Project management and serve as Quality Control representative for internal and external clients, both commercial and non-commercial and, as required, CMOs
•Proficient in process and data review within respective scientific field of operation in accordance with job responsibility and function, able to troubleshoot instrument, method and technique-related issues
•Correctly operate and maintain laboratory equipment, foresight relating to recommending replacement or upgrade to better meet business needs
•Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)
•Resolve conflicts within the group relating to performance and/or workload as well as ensure proper resource allocation within and across teams
•Perform other duties related to the position when required by management
•PhD Analytical Chemistry (or equivalent degree) with four years of professional experience in pharmaceutical analytical chemistry, or
•Master’s Degree in Chemistry (or equivalent degree such as Pharmaceutical Sciences) with six years of professional experience in pharmaceutical analytical chemistry, or
•BS or BA degree in Chemistry (or equivalent degree such as Pharmaceutical Sciences) with eight years of professional experience in pharmaceutical analytical chemistry
•BS or BA degree Biology with ten years of professional experience in pharmaceutical analytical chemistry
•Majority of work day is performed while standing, walking, lifting, pulling, pushing
•Requires the ability community effectively using speech, vision and hearing
•Requires the use of hands for simple grasping and fine manipulations
•Requires the ability to stand for extended periods of time
•Some exposure to hazardous chemical and other active chemical ingredients
North Carolina Biotechnology Center