MilliporeSigma Quality Assurance Supervisor in Saint Louis, Missouri
A career with MilliporeSigma is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany. Your Role: Manages a team responsible for Quality oversight of custom API manufacturing according ICH Q7A and cGMP regulations. In support of site wide objectives, supervises floor support activities, reviews and may be delegated to approve area documents such as Batch Records, Environmental Compliance records, SOPs, deviation investigations, validation protocols and reports, CAPAs and Change Requests. Coordinates Quality support of production preparation and operation. Engaged with cross functional teams as needed to support continuous improvement activities. Requires decision making ability related to Incident Investigation initiation, with emphasis on overall quality, site priorities, results and achievements. ROLE RESPONSIBILITIES * Implement and execute procedures to assure compliance with regulatory requirements and internal policies. * Provide feedback as requested to continuously improve technical training effectiveness and efficiency. * Direct aspects of batch record review and release for raw and final products produced under GMP conditions. * Recognize areas of quality systems that exhibit an opportunity for improvement ex. Documentation management, Complaints, Training, etc. based upon business, customer, and regulatory requirements and develop, implement, and maintain these Quality Systems. * Supports operational excellence and site transformational initiatives. * Support for processes to hire, develop, coach, reward and monitor training and communication staff members. * Set and implement objectives and development plans for direct staff. * Work with site leadership to develop site specific messaging including site objectives. * Support communication process improvements throughout the site and enable replication of good practices between sites. * Support the development of project plans for specific quality system initiatives and process improvements * Coordinate the selection, training, development, motivation, and evaluation of employees. * Evaluate employee performance against expected job requirements. * Mentor employees in meeting or exceeding expected job requirements, by ensuring skills and knowledge development occurs to allow employees to maximize performance in current positions. Who You Are The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.Employer's Job# 175236Please visit job URL for more information about this opening and to view EOE statement.