Genentech Quality Assurance Lead in Indiana,
Quality Assurance Lead
Job ID: 202010-126028
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Develops, maintains and ensures compliance with quality programs, policies, processes, procedures and that the performance and quality of products conform to established standards, specifications and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to ensure that inspections, process control analyses or audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. Ensures the quality assurance programs and policies are maintained and modified regularly. Establishes and ensures that inspections are conducted prior to the processing of raw materials, ingredients, product, and package specifications, frequently at vendor/supplier locations. May serve as liaison between the company and the various governmental agencies.
Specialized and in-depth comprehensive knowledge and experience in a particular field, or business area. Duties are varied and complex often involving research, analysis and solution development. Provides direction on issues of area of expertise and assist department leadership in setting strategic direction. Typically a higher level professional position. Requires the regular use of originality and ingenuity. Possesses and applies a broad knowledge of principles, practices and procedures of field. Is generally assigned more complex and difficult assignments. Assignments are broad in nature. Typically works with greater discretion and latitude. May assist Consultants and lower level staff by providing advice and guidance.
Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
KEY ROLES & RESPONSIBILITIES
Provides guidance and leadership to departments on the implementation of new instruments and quality improvement process and corrective actions in compliant with regulations and standards.
Establishes and ensures compliance with good housekeeping practices, employee hygiene and equipment sanitation; analyzes plant error, salvage, spoilage reports and process statistics for significant findings and conclusions; establishes policy and strategy during new product start-ups, and key checkpoints for new products and processes.
Is the liaison with other departments and organizations on contracts and advanced projects.
Bachelors degree in related field and 8+ years of related experience OR 12+ years of related experience
Excellent problem solving, customer service, negotiation, interpersonal, decision making, leadership and communication skills
Highest level of knowledge of technology industry quality standards
High level of knowledge of product development objectives and strategies
High level of knowledge of business operations to create requirements for product development
Advanced project management and technical business analysis skills
Excellent organizational, decision-making, human relations and communication skills
Ability to resolve problems in a timely manner
Strong knowledge and understanding of quality, manufacturing, planning, supply chain, inventory management and/or traffic processes and procedures
Who We Are
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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