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: Ensure that all aspects of product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems. Support the maintenance, development, and improvement of GMP quality systems, such as auditing (internal, supplier, and customer), training, validation, change control, complaint handling, and document control.
- Review executed GMP batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release. Report all process deviations and/or laboratory OOS results.
- Prepare Batch Specific Documentation Packages
- Write and/or review operating procedures, master manufacturing documents, and other QA controlled documents for all departments.
- Participate in internal audits as needed.
- Respond to quality related customer questions.
- Present various GMP quality systems training topics to production, laboratory, and quality personnel, if needed.
- Assist in the resolution of customer complaints pertaining to quality and process related issues, if needed.
- Interact with production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
- Support project or process improvement initiatives.
Who You Are
- Bachelor's Degree with 0 - 2 years experience in GMP manufacturing, validation, QA, QC, or other functional areas applicable to the job. OR Associate's Degree with 3 -5 years experience in GMP manufacturing, validation, QA, QC, or other functional areas applicable to the job.
- Must have an understanding of quality control methodology and the associated analytical results.
- Excellent interpersonal skills are required for communication with internal departments along with customers, suppliers, and regulatory authorities.
- Ability to organize and prioritize tasks effectively.
- Capacity for independent work.
- Excellent time management and negotiation skills required.
- Good Computer 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.