A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 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: The QA Supervisor, Systems and Product Support role is to initiate and manage the implementation and maintenance of quality systems, and coordinate quality initiatives with other Operations departments. Ensure proper quality levels are being met for final product support systems according to GMP and ISO requirements.
ESSENTIAL JOB FUNCTIONS
- To demonstrate leadership in developing and implementing quality system initiatives in all areas of Operations (cGMP and ISO).
- Recognize those 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 to ensure we are at or above industry standards.
- Support the Development of project plans for specific quality system initiatives and process improvements.
- Work with representatives from the various operational areas to measure current process and implement changes using PDSA methodology
- Maintain current understanding of GMP regulations and apply and interpret regulations in making business decisions and risk assessments.
- Work with other departments, divisions, and sites to solve problems, improve service, reduce costs, and enhance programs within the Quality Management System.
- Supervise 6 - 8 employees including coordinating 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.
- Identify and develop those employees with the potential and interest to pursue supervisory responsibilities.
- Ensure personnel are treated with respect and dignity with an emphasis on providing a strong avenue for communication and company values.
- Support process improvement activities outside of Quality Assurance
- Work with other manufacturing facilities on quality projects and support product initiatives or custom business opportunities.
- Maintains and distributes a summary of Quality metrics/KPI.
- Work with other departments or customers to resolve product or service problems to the benefit of the customer and the quality objectives
- Manage Quality Systems in support of GMPs including documentation system, training system, etc.
- Manage product support including DMF content, annual reports, product statements.
- Review Quality Agreements for ability to meet customer specific requirements.
- Manage and coordinate personnel to maintain adequate resources to review and release product in pace with Operations.
- Manage the incoming raw material and repack functions located at remote site.
- Lead process improvement efforts within Quality Assurance.
- Mentor employees to actively participate in projects to improve quality systems or processes, and establish Performance Goals & Objectives.
- Communicate the importance of systematic process improvement to all employees and incorporate these concepts into the culture of the group.
Who You Are
- Bachelor’s degree in science or related field and a minimum of 3+ years of experience in Quality aspects of a GMP / regulated industry.
- Strong leadership skills with a successful track record of personnel development.
- Full understanding of the regulatory requirements governing Pharmaceuticals and ISO Quality Management System Requirements.
- Quality systems management. Good understanding of Validation, Qualification, and the following problem solving techniques: Pareto analysis, flowcharts, PDSA, Cause and Effect Analysis, and Fishbone Root Cause Analysis.
- Basic budgetary planning, capital expenditure justification,
- Knowledge and skills
- Advanced written and verbal communication
- Good Problem solving
- Ability to organize tasks effectively with good Time Management and multiple tasking capabilities
- Advanced Interpersonal skills with ability to act as a mentor to staff and co-workers.
- Ability to lead & implement Project Initiatives.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
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.