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The most important tasks for this individual will be generating and compiling lab metrics and assisting with lab instrument implementations. So protocol and report writing are also critical. AS well as, statistics and a mastery of Excel for the metrics.
Responsible for managing and coordinating the activities of the Quality Control associates engaged in sorting, testing, and inspecting products and raw materials in order to ensure compliance with quality standards and production schedules. At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc
• Communicates department objectives and metrics.
• Implements changes in production methods, tooling and equipment, space allocations, workforce utilization, production schedules, lines and other factors required to maintain or improve compliance with quality standards of existing products and to establish initial and continuing compliance with quality standards for new and/or redesigned products.
• Initiates audits to verify that prompt and appropriate actions and associated corrections are taken.
• Communicates metrics and systems used to measure and guide improvements to product and system quality and customer satisfaction to quality control staff.
• Provides input to quality control reports, requirements and other information in response to requests for proposals, quotes and other business opportunities.
• Makes recommendations to management regarding ways to improve manufacturing processes and increase product quality and delivery while reducing production costs.
• Prepare, revise, and implement SOP’s related to the laboratory and/or laboratory systems in order to maintain compliant with GLP and current regulatory expectations.
• Assures that instruments used in the test methods are calibrated, maintained and operating properly.
• Confers with management on various problems and works in conjunction to develop or improve methodology.
• Assures that assigned personnel adhere to departmental safety policies.
• Acquires, maintains and applies current professional knowledge and skills appropriate to the job.
• Embraces and demonstrates Pharmaceutical leadership competencies on an ongoing basis.
• Provide technical expertise to colleagues regarding the interpretation and/or implementation of cGMP laboratory practices.
• Troubleshoot laboratory equipment and methodologies.
• Perform appropriate training of laboratory employees in their job functions, provide quality systems, task training, and report laboratory metrics.
• Implement continuous mitigation and improvement programs within the laboratory.
• Adheres to regulatory, Pharmaceutical and departmental requirements.
• Ensure quality and compliance in all my actions by:
Bachelor's degree in Chemistry or closely related field is required from a four-year college or university; or equivalent combination of education and experience.
Minimum of 6 (six) to 8 (eight) years of experience in analytical chemistry preferably in the pharmaceutical or consumer healthcare industry. Analytical instrumentation experience and knowledge of GMPs
Required Knowledge, Skills and Abilities:
• Experience in Analytical testing in a pharmaceutical, OTC, or cosmetic laboratory
• Experience in a quality assurance environment preferred
• Knowledge of USP regulations in the pharmaceutical industry
• Experience with current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (cGMPs).
• Experience in a GLP/GMP FDA regulated facility manufacturing consumer or pharmaceutical products.
• Experience in conducting, executing, and leading analytical investigations
Location of Role: Lititz, PA
Language Requirements: English
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