A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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.
Support the maintenance, development and improvement of quality systems, such as auditing (internal, supplier and customer), training, process validation, cleaning validation, equipment qualification, change control, complaint handling, documentation control, Management of deviations and complaints, CAPA Management and ensure MilliporeSigma's compliance with government regulations. This includes coordinating with both suppliers and customer to develop consistent, efficient business practices that comply with related regulations.
Who You Are:Minimum Qualifications:
- Review controlled documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release.
- Report all process deviations and/or laboratory OOS results. Investigate QA-pertinent process anomalies.
- Recognize areas of quality systems that exhibit an opportunity for improvement (ex. Documentation management, Training, Regulatory submissions, etc.) based upon business, customer, and regulatory requirements and develop, implement, and maintain these Quality Systems to ensure a level at or above industry standards.
- Support the Development of project plans for specific quality system initiatives and process improvements.
- Maintain current understanding of quality systems for business units including DPM and serum products and apply and interpret regulations in making business decisions and risk assessments.
- Prepare affidavits for export and miscellaneous regulatory statements as related to customer inquiries.
- Management of EDQM Certificates.
- Maintain a calendar with due dates for all records, registrations and reports.
- Preparation of confidential and proprietary documents and agreement.
- Management of document storage and retrieval supporting the Lenexa site.
- Support the Management of Change Program for all product quality-related changes to training curriculums, documents, equipment, specifications, and methods.
- Support the Site as a Site Lead User (SLU) for EDMS. TrackWise, and Learning Management System.
- Interact with site personnel regularly to ensure adequate communication and feedback for quality related services to internal customers.
- Work with other departments or customers to resolve product or service problems to the benefit of the customer and the quality objectives.
- Participate in internal audit program as a lead auditor.
- Manage and investigate nonconformities (Deviations) and Corrective and Preventative actions.
- Take part in and contribute to a safe working environment by following corporate and departmental safety regulations.
- Perform other job duties as required.
- Bachelor's Degree and 2+ years of experience in Quality Assurance
- High School Diploma or GED equivalent and 5+ years of experience in Quality Assurance
- 2+ years of experience in GMP manufacturing, validation, QA, QC or other functional area applicable to the job.
- 1+ years of experience with import/export compliance, ISO, document control, management of change, risk mitigation, and Quality Systems.
What we offer:
- Careful attention to detail.
- Strong investigation and problem-solving skills.
- Ability to make decisions using a risk-based approach.
- Advanced written skills for technical protocols and reports, as well as response customer letters.
- Familiarity with ISO 9001/2015, cGMP, EDQM Certificates of Suitability.
- Working knowledge of FDA and/or USDA regulatory requirements.
- Candidate must have experience with Microsoft Access, Excel, and Word.
- Strong time management skills.
- Excellent interpersonal skills for interacting with many internal departments and management levels, along with customer, suppliers, and regulatory authorities.
- Ability to organize and prioritize tasks effectively.
- Self-motivated and able to work independently.
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 https://jobs.vibrantm.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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Job Requisition ID: 215442
Career Level: D - Professional (4-9 years)
Working time model: full-time
This job has expired.