AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The primary role of the Manager, Package and Medical Device testing is to oversee and direct laboratory personnel in the planning and execution of physical package testing and device testing projects in a timely manner as required by customer needs.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage and supervise laboratory personnel.
Support sales growth with e-marketing, client visits, blogs, press releases, etc.
Manage multiple projects at any one time ensuring all commitments are met.
Manage test samples including sample intake, retains and sample disposition for the Package and Medical Device Testing Laboratory.
Verify client and sample information, test methods, and test specifications.
Oversee proper handling of controlled substances for the Package and Medical Device Testing Laboratory
Ensures departments operates in compliance with all Quality, EH&S and regulatory (i.e. FDA, OSHA, DEA, EPA, etc) requirements and initiatives.
Perform necessary deviations or OOT investigations. Determine and implement necessary CAPAs if applicable
Ensure SOPs are kept current and are followed by staff
Open necessary Change Controls, execute appropriate actions related to the change and close the change control.
Keep a working knowledge of commonly prescribed methods, background information, and troubleshooting strategies.
Prepare test protocols/methods as required.
When necessary, conducts analytical testing, record results, and keeps a detailed laboratory log
Analyze, interpret and communicate test results to senior management and clients.
Author and review laboratory testing reports and/or associated technical documentation.
Manage the maintenance and operation of laboratory equipment, instruments and logbooks including calibrations, performance verification and equipment IQ/OQ/PQ.
Provide training to lab personnel for test procedures and methods as required
College Degree in Engineering or Life Sciences required and 5-10 years of relevant experience in a laboratory environment.
Good written, math and verbal skills; highly organized and decision-making ability focused around details.
Ability to work independently, take initiative and handle multiple tasks within defined timelines.
Knowledge of lab quality systems, cGMPs, and document control methods required.
All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.
AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical Services, API Manufacturing and Drug Product. We’ve got it down to an exact science.