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Sr. Quality Specialist
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.
The Sr. Quality Specialist will report to the QA Manager – Quality Systems, Audits & Inspections. As a member of the Quality Assurance organization, you will be responsible for coordination and oversight of site Quality Systems.
This role is an individual contributor position, with Lead responsibilities to be assigned within the Quality Systems team. This role requires the ability to independently manage timelines and effectively communicate with team member, cross-functional stakeholders, clients and external regulatory representatives. Additional responsibilities of this role may include:
- Support the creation, review, approval, execution, extension, and/or closure of site Deviations (Events), CAPAs and Change Controls
- Complete, review, and/or approve site Risk Assessments
- Hold/Support Change Management/Control Review Board meetings
- Communicate with clients, as needed, in relation to changes
- Act as site SME on Change Control and conduct site trainings
- Hold/Support CAPA Review Board Meetings
- Measure/Monitor Quality System data and submit monthly metrics to Quality Management
- Gather data for client Annual Product Reviews as needed
- Support Client Audits and Regulatory Inspections as needed
Who you are:
- Bachelor’s degree in Quality or Science or a scientific discipline
- 4+ years of experience working within Quality in a cGMP environment
- 6+ years of experience with a cGMP Change Control or Change Management program
- 3+ years of Change Control/Change Management Program experience and/or 3+ years of CAPA Program Management experience
- 3+ years coordinating Quality System records and drive to completion
- 3+ years of experience supporting client audits and regulatory inspections
- Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
- Certified Quality Auditor
- Contract Manufactured Organization (CMO) experience
- Ability to work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities.
- Strong interpersonal communication skills
- Organized and detailed oriented with strong and effective written and verbal skills
- Ability to work independently within prescribed guidelines and collaboratively as part of a coordinator and as part of a team
- Proven ability to obtain direction and commitment to ensure that objectives are completed by due dates.
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 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.