PALL LIFE SCIENCES
There is no greater calling or opportunity for a fluid management company than today’s challenge – helping customers protect people, the environment and our natural resources. Together we are implementing technologies that purify and conserve water, consume less energy, make alternative energy sources possible and practical, advance medicine and minimize emissions and waste. Our collective efforts are enabling a greener more sustainable future.
Pall is a Fortune 1000 materials science and engineering company with the broadest filtration, separation and purification capabilities in the world. Our process and product enabling technologies help our customers make good products better, safer and even possible. We provide innovative products to customers in health care, biotechnology, pharmaceutical, semiconductor, municipal drinking water, aerospace and industrial manufacturing markets.
Headquartered in Long Island, NY, Pall has operations in every major country.
QA Director - Pensacola, FL
The QA Director is responsible to maintain comprehensive, cost-effective, and progressive quality standards for the plant products of Pall. Activities typically include: developing procedures that maximize quality standards; establishing and directing laboratory facilities for quality testing of raw materials, finished goods, and goods in process. Develops strategies and implement programs to assure regulatory compliance and standards of quality to meet business objectives. Provides leadership in responding to Product Quality, Customer Audit trends and Regulatory requirements. Manages Quality Systems compliance audit programs. Executes control over all or some of the following programs/systems: the change control system, documentation control, product complaint investigation and analysis. Manages process improvement through Quality Engineering.
Maintains quality staff by recruiting, selecting, orienting, and training employees; maintaining a safe and secure work environment; developing personal growth opportunities.
Accomplishes staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures.
Establishes quality strategic goals by gathering business, financial, service, and operations information; identifying and evaluating trends and options; choosing a course of action; defining objectives; evaluating outcomes.
Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
Maintains quality service by enforcing quality and customer service standards; analyzing and resolving quality and customer service problems; identifying trends; recommending system improvements.
Participates, as member of management team, in formulating and establishing organizational policies and operating procedures for company and develops, implements, and coordinates, through support staff and lower echelon managers, product assurance program by preventing or eliminating defects in new or existing products.
Analyze, evaluates, and presents information concerning factors, such as business situations, production capabilities, manufacturing problems, economic trends, and design and development of new products by involving other members of management team for their consideration.
Develops and implements alternative methods and procedures in solving problems by meeting changing market opportunities.
Cooperates with other top management personnel by formulating and establishing company policies, operating procedures, and goals.
Develops initial and subsequent modifications of product assurance program by delineating areas of responsibility, personnel requirements, and operational procedures within program, according to and consistent with company goals and policies.
Evaluates contents of reports from product assurance program department heads and confers with top management personnel by formulating fiscal budget for product assurance program.
Conducts management meetings by establishing, delineating and reviewing program organizational policies, by coordinating functions and operations between departments, and by establishing responsibilities and procedures for attaining objectives.
Reviews technical problems and procedures of departments by recommending solutions to problems or changes in procedures.
Visits and confers with representatives of material and component vendors by obtaining information related to supply quality, capacity of vendor by meeting orders, and vendor quality standards.
Confers with engineers about quality assurance of new products designed and manufactured products by rectifying problems.
Develop auditing procedures and techniques by establishing and meeting quality standards at a minimum cost.
Prepares for and represents company during all related audits.
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
Contributes to team effort by accomplishing related results; keeping business information confidential; administering the system security; ensuring data accuracy and integrity; maintaining updated professional and technical knowledge; assuring systems compliance with laws, regulations, and corporate standards; ensuring a safe and healthy environment.
Complies with ISO 9000 and all applicable regulations and company procedures.
Lead continual improvement projects to reduce, minimize or eliminate environmental aspects/impacts within his/her area of operations.
Bachelor’s degree in Chemistry, Biology or Engineering or Master’s degree in Science.
Minimum ten (10) years of significant manufacturing experience in GMP and regulatory compliance activities within the pharmaceutical or medical device industry.
Proven experience leading a Quality function or assuring Quality within a manufacturing plant environment including strong knowledge of regulations such as ISO 9001 international standards and cGMP guidelines, supplier quality programs, new product introductions, Quality audit procedures, systems compliance, corporate standards, data integrity, and quality testing of raw materials, finished goods, and goods in process to meet business objectives and timelines.
Experience in preparing and operating within projected functions budgets.
Demonstrated experience working cross functionally to drive process improvements, Quality audits, and accountability for Quality process with operations leadership and all levels of the organization.
Experience with change control systems, documentation control, product compliant investigation and analysis and managing process improvement through Quality Engineering.
CQE, CQM, CQA, Six Sigma, ISO Lead Assessor certifications are a plus
We offer competitive compensation, a comprehensive array of benefits, and the opportunity to work with a dynamic team of professionals.
To apply for this position please visit our site at www.pall.com and go to the careers section.
The tracking code for this is LC-130121122437
Equal Opportunity Employer
Pall Corporation is committed to equal opportunities to all without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age, marital status, disability, veteran's status or any other personal trait protected by federal, state or local law.
With operations around the globe, Pall is not small. The company operates two businesses globally: Life Sciences and Industrial. The Life...