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.
Positions within QA vary depending on the specific needs. This position works on and leads extremely complex problems, in which analysis requires an evaluation of intangible variables. The individual must exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining results. The ability to evaluate risk versus benefit to the organization and its customers is essential. Acts independently to determine methods and procedures and may supervise the activities of lower-level personnel.
- Manages the department, under direction of the department manager
- Monitors workflow and sets priorities to ensure timely processing of items through work area, consistent with departmental goals
- Makes strategic recommendations for capital investment and operational budgets
- Assists with preparation and monitoring of department budget
- Handles confidential company information properly
- Ensure that employees are trained in all safety, PPE, regulatory, ISO, cGMP and company QMS (Quality Management) procedures
- Serve as resource for employees, customers, vendors and affiliates
- Assist in the investigation of customer complaints
- Participates in talent selection process
- Engages in performance management and discussions to retain and develop employees
- Resolves and maintains employee relations through effective communication for the area including, team meetings and daily interaction
- Responsible for maintaining confidential information of employees
- Mentors and leads daily activities
- Recognize and initiate near miss reports. Complete accident/incident investigation reports within required time
- Conducts audits for compliance to procedures, rules and regulations. Provide feedback for both safe and unsafe actions
- Review and revise departmental SOPs.
- Monitor resources daily and schedules workload and staff accordingly for the Quality Assurance department
- Schedules staffing to accomplish tasks
- Distributes work assignments
- Facilitates participation from direct reports with process improvement projects
- Reviews Quality Assurance operation and recommends improvements
- Represents department and the site during internal and external audits
- Coordinate with Sales & Marketing, Packaging Engineering, Procurement, Production, Packaging, Compliance and Carriers, Quality Services, and Freight Forwarders to resolve concerns
- Demonstrates the ability to effectively negotiate within internal and external departments to achieve the best versus easiest/most popular outcomes
- Leads large scale, cross functional projects of diversified scope
- Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within defined practices and policies and selecting methods and techniques for obtaining solutions
- Manage and maintain multiple projects and timelines with minimal supervision
- Review changes for impact on customers overall cost vs. benefit.
- Maintain and improve our QMS (Quality Management Systems), safety, ISO 9000 and cGMP practices
- Employ and direct process improvements using PDSA, Six-Sigma, and lean methodology
- Ensure that training, documentation and calibration programs are in compliance
- Review, revise and approve ISO 9000 procedures; oversee proper handling of test results supporting documentation for cGMP procedures
- Review area and test/recommend changes to increase productivity
- Miscellaneous duties and tasks as assigned
Who You Are
Previously demonstrated leadership ability, including excellent communication skills both verbally and written. Basic understanding of Quality System Regulations (e.g. 21 CFR, Part 820, 211, 600 and Q7A) and other FDA regulations such as complaints and Medical Device reporting, with a thorough understanding of the ISO quality management system requirements. Thorough understanding of the principles of process, cleaning, and equipment calibration, verification, and validation. In depth understanding of auditing. Good computer skills, including proficiency in MS Word, MS Excel, MS Access, and knowledge of company mainframe systems (SAP, QCSS, etc.) Data analysis and presentation, experimental design. Preferred understanding of MilliporeSigma operations, including production, packaging, laboratory, materials management, purchasing, and others. Effective written and oral communication and customer service skills. Ability to simultaneously manage multiple tasks/priorities. Excellent problem solving skills/abilities. Capacity for independent work. Good time management skills. Good negotiating skills.
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.