Industry: Medical Devices & Diagnostics•
5 - 7 years
Posted 294 days ago
Great opportunity to join an expanding global leader as the site Manager, Analytical QC laboratory with responsibility to provide internal and external customers with accurate, reliable and timely test results for raw materials, in-process and finished goods for this cGMP compliant environment. Strong leadership skills are required to develop, train and manage a team of chemists and technicians supporting this 4 shift operation.
--- Manage and direct the Quality Control/ Analytical Laboratory operations within the approved expense and capital budgets.
--- Maintain appropriate laboratory statistical process control including test method performance specifications, equipment operational specifications, and SPC charting
--- Maintain qualification and verification documentation for laboratory instrumentation and equipment
--- Maintain documentation to show compliance with applicable cGMP requirements
--- Review all analytical data including that used for raw material, in-process, and finished good release, and environmental assessment
--- Ensure that laboratory test method standards, controls, references, raw materials, reagents and solutions are purchased, labeled, and stored properly for reliability and availability when needed, and within expiration.
--- Represent corporate and local Quality Control on interdepartmental and inter-site teams
--- Communicate within Quality, between departments, between locations, with external customers, and with contract facilities
--- BS in Chemistry, Biochemistry or related with 5+ years experience in Quality Control and Analytical Laboratory Leadership within cGMP, FDA regulated plant environments - pharmaceuticals, food, or liquid nutraceuticals.
--- Must have working knowledge of laboratory equipment including; GC, ICP and HPLC.
--- Understanding of LIMS, cGMP, FCC, USP/NF, and AOCS requirements and test methodology.
--- Computer proficiency in Microsoft Office and various instrument operating systems.
--- Experience with statistical analysis and control charting preferred.
--- Able to work in the USA without sponsorship, now or in the future.