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Quality Assurance Specialist
A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
MilliporeSigma has an opening as a Quality Assurance (QA) Specialist at our Round Rock location. The Quality Assurance Specialist will efficiently review and release quality production documents ensuring QA activities are aligned with quality documents and procedures in addition to customer and market requirements. The role includes the following:
- Coordinate and perform review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications, and methods.
- Perform document record review and approval of batch records, equipment qualifications, calibration records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy.
- Generate and review Certificate of Analysis (CoA) for catalog and custom projects.
- Assist in the preparation and hosting of external audits including customer, ISO, and DEA audits.
- Generate quarterly metrics summarizing documentation review and production activities.
- Perform review and approval of Standard Operating Procedures to ensure compliance with regulatory and company quality requirements.
- Regularly communicate with the QA management any problems and concerns that may delay or lead to the failure of the completion of projects, qualifications, validations, or other quality documents.
- Assist with internal audits as needed to maintain audit schedule.
- Support rollout of local and corporate initiatives.
Who You Are:
- High School Diploma or GED with 5+ years of experience in a GMP, GLP, FDA, ISO or other regulated environment OR Bachelor's Degree in a Life Science discipline 1+ year of experience in a GMP, GLP, FDA, ISO or another regulated environment
- Knowledge of ISO 9001, ISO 17025, ISO 17034, and ISO 14001
- Knowledge of quality system requirements of the pharmaceutical and/or clinical industries.
- Excellent communication skills. The ability to respond to colleagues effectively, both verbally and in writing.
- The ability to interact and work well with other team members.
- The employee must be able to approach others to discuss work-related items in a manner that will allow for a successful outcome.
- Strong technical knowledge base and the ability to comprehend and communicate basic technical concepts.
- Self-motivated and able to work independently.
- The candidate must be able to critically review documents for discrepancies with written procedures and requirements.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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.
As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.