Objective of Position The QA Supervisor will be responsible for managing a team of quality assurance / quality control and compliance professionals in the development, implementation, and maintenance of quality assurance systems in support of our manufacturing facility at 250 Windy Point Drive, Glendale Heights, Illinois.

Responsibility Responsibilities include nonconformance reporting, GMP / QSR investigations, corrective and preventive actions, GMP / QSR document changes, change control and performance metrics.

Advising the staff on changes and their implementation and provides training tools and techniques to enable others to achieve Compliance.

Knowledge of GMP / QSR regulations and interfacing with regulatory agencies is essential.

Specific Duties ˜ Manage a team of quality professionals to achieve quality, compliance and business objectives.

˜ Analyze, develop and improve quality systems and associated business processes to achieve compliance with global regulatory requirements.

˜ Develop and maintain policies, standards, procedures, and guidelines encompassing all quality systems and facilitate deployment.

˜ Take a leadership role in quality programs and initiatives, make recommendations to continuously improve systems.

˜ Responsible to conduct internal compliance audits, manage timelines and schedules, generate audit reports, review audit responses and conduct follow up to track resolution.

˜ Support investigation activities utilizing root cause and problem solving methodologies as well as support CAPA development and implementation.

˜ Contribute to the design plan and execution of validation studies.

˜ Develop and maintain department and site metrics for monitoring critical process and quality attributes.

˜ Review and approve appropriate technical documentation in support of cross functional and cross departmental projects.

˜ Act as ISO Management Representative˜ Perform other duties as assigned Shared Duties ˜ Support during project upgrades and modifications˜ Implementation of corporate image˜ Internal coordination tasks and activities˜ Manage client and regulatory audits˜ OSHA regulation awareness˜ Interactions with Manufacturing Operations, Process Engineering, Validation Services, External Vendors / Service Providers.

Qualifications ˜ 5 plus years of commensurate experience in quality assurance (QA) with increasing responsibilities, within the pharmaceutical / medical device industry.

˜ 2 plus years if experience as a manager or in a leadership role within the QA organization in pharmaceutical / medical device industry preferably in an aseptic manufacturing environment.

˜ In-depth working knowledge of cGMP, QSR, 21 CFR, ISO 13485, ISO 9001, ICH and all other applicable international regulations, standards, Directives and Guidance.

˜ In-depth knowledge of developing and deploying quality systems within pharmaceutical / medical device industry.

˜ Strong analytical skills with proficiency in the application of problem-solving and root cause analysis methodologies.

˜ Strong verbal and written communication skills˜ Strong managerial skills and a team player.

˜ Ability to multi-task and manage priorities.

˜ Ability to interface at all technical levels.

Medefil, Inc. is one of the leading manufacturers of pre-filled syringes in USA. This is a highly visible position with responsibility for leading and directing a team.

Medefil offers attractive salary, strong benefits including 401(k) and career growth.

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