Lornamead is currently seeking a Quality Laboratory Manager to join our team!
Lornamead Products, headquartered in Tonawanda, NY, manufactures and supplies, hair care, skin care, oral care, and bath products in America. The company offers toothpastes, teeth whitening products and oral analgesics for drug chains, and national food retailers.
Your Challenge
The Quality Laboratory Manager is responsible for the overall management, leadership, and compliance of the analytical laboratory supporting OTC drug and cosmetic manufacturing operations. This position ensures laboratory activities comply with current Good Manufacturing Practices (cGMP), FDA regulations, MoCRA requirements, ANSI 455-3/455-4, ISO 22716, and internal quality system requirements. The role directs laboratory personnel, oversees testing, data integrity, method validation, investigations, and supports regulatory inspections.
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Lead and manage all analytical laboratory operations, personnel, budgets, resource planning, and succession planning to support business and quality objectives.
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Direct testing of raw materials, packaging components, in-process materials, finished products, stability samples, water systems, retains, and contract laboratory activities.
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Ensure laboratory compliance with FDA cGMP (21 CFR Parts 210/211), MoCRA, ANSI 455-3/455-4, ISO 22716, ALCOA+ Data Integrity principles, and applicable compendial and customer requirements.
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Manage the laboratory Quality Management System, including SOPs, specifications, test methods, Certificates of Analysis, Change Controls, Deviations, CAPAs, OOS/OOT investigations, risk assessments, and laboratory documentation.
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Oversee analytical method development, validation, verification, transfer, revalidation, and continuous improvement to ensure reliable and compliant testing.
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Manage laboratory equipment throughout its lifecycle, including qualification, calibration, preventive maintenance, and replacement planning.
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Direct the stability program, including protocol management, sample scheduling, chamber qualification, trend analysis, and shelf-life/expiration dating support.
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Lead technical investigations, troubleshoot laboratory and manufacturing issues, and provide analytical support for formulation development, scale-up, process improvements, and product quality initiatives.
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Evaluate, qualify, and routinely audit contract laboratories to ensure continued technical competence and regulatory compliance.
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Support new product development by developing analytical methods, evaluating new technologies and instrumentation, and providing technical solutions that meet business objectives.
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Represent the laboratory during FDA inspections, customer audits, certification audits, and regulatory interactions, ensuring timely and effective responses.
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Drive continuous improvement through laboratory automation, LIMS implementation, KPI monitoring, operational excellence initiatives, and employee training and development.
Qualifications
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Degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or related scientific discipline.
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Ability to perform, at a minimum, FTIR, HPLC, GC, titration, viscosity, pH, specific gravity, and ion selective electrode analyses. Performs limited troubleshooting and calibration of instruments.
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Effectively present information and respond to questions from groups of managers, clients, customers, and auditors.
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Deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.).
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Prioritize workload to ensure all turnaround times are met.
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Prepare and review written technical reports. Write reports, summaries, and protocols regarding experiments.
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Performing tests in a laboratory environment can include analysis, assembling and disassembling, and attempting destruction or chemical variations of products to ensure quality. Results are then reported to help improve manufacturing processes.
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Responsible for performing a wide variety of research laboratory tasks and experiments, making detailed observations, analyzing data, and interpreting results.
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Maintains laboratory equipment and inventory levels for laboratory supplies.
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Maintains familiarity with current scientific literature and contributes to the process of a project within his or her scientific discipline, as well as investigating, creating, and developing new methods and technologies for project advancement.
