Quality Specialist I
MilliporeSigma

Job Info

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A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

This role contributes to or impacts the results of the Quality Assurance (QA) team and is accountable for the quality of own work. Receives clear instruction, guidance and direction from more senior level roles or solves problems of low complexity independently by identifying and selecting solutions and by analyzing information.

Theindividualperforms a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation.

• Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers and other quality records
• Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis
• Review and approve validation files for systems and assays
• Review and approve deviation records
• Conduct laboratory inspections

Who You Are:

Minimum Qualifications:

• Bachelor's degree in a scientific (i.e., Biology, Chemistry, etc.) or technical (i.e., Chemical Engineering, Materials Engineering, etc.) discipline
• 6+ monthsexperiencewithin a GxP environment

Preferred Qualifications:

• Basic knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211 etc.)
• Experience in Quality Assurance or related field within aGxPenvironment
• Familiarity with International regulations (EMA, MHRA)
• Strong oral and written communication and interpersonal skills
• Acts ethically and ensures quality of own work and that of others
• Takes responsibility for ensuring that turnaround times are met
• Works with cross-functional teams and builds networks within QA and Operations departments
• Open-minded, flexible and works with agility

RSRMS

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!

Our Benefits -http://jobs.vibrantm.com/emd/content/Benefits-at-a-Glance/?locale=en_US

Curious? Apply and find more information at https://jobs.vibrantm.com

If you are a resident of a 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.

Job Requisition ID: 236244

Location: Rockville

Career Level: C - Professional (1-3 years)

Working time model: full-time

This job has expired.