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Sr. Quality 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.
We are offering a $7,500 sign-on bonus for those that qualify!
The Sr. Quality Assurance (QA) Specialist is an individual contributor position with lead responsibilities to be assigned by the Quality Assurance (QA) Manager. The Sr. QA Specialist reports to the QA Manager and is responsible for the operation, coordination, and oversight of Quality Systems.
The role is a key Quality contact at the SAFC Carlsbad Site for QA support of Quality Systems and requires the ability to independently manage timelines and effectively communicate with team members, cross-functional stakeholders, clients, and external regulatory representatives while helping to maintain site Quality Systems in a state of inspection readiness.
Additional responsibilities of this role include:
- Support the creation, review, approval, execution, extension, and / or closure of site Deviations (Events), CAPAs, and Change Controls
- Complete, review, and/or approval of site Risk Assessments
- Facilitate / conduct Change Control Review Board meetings
- Support client communications / notifications as needed in relation to changes
- Act as site SME on quality system processes, e.g., Change Control, CAPA, Deviations, etc.
- Facilitate / conduct CAPA Review Board Meetings
- Measure/Monitor Quality System data and submit monthly metrics to Quality Management
- Assist with gathering data for client Annual Product Reviews as needed
- Support Client Audits and Regulatory Inspections as needed
Who You Are:
- Bachelor’s degree in a scientific discipline
- 4+ years of experience in Quality within a cGMP environment
- Experience working at a Contract Manufacturing Organization (CMO) or similar type environment
- Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
- Ability to work successfully, strategically, and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities.
- Experience with cGMP Change Control or Change Management program
- Ability to assess Quality System records and drive to completion
- Experience supporting client audits and regulatory inspections
- Organized and detail oriented
- Strong written and verbal skills
- Strong interpersonal communication skills
- Ability to work individually and collaboratively as part of a team
- Proven ability to obtain direction and commit to ensuring that objectives are completed by due dates
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.