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Sr.Quality Assurance Associate
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.
As a member of the Sr. Quality Assurance Operations team, you will be responsible for the critical quality review of records associated with raw materials, ensuring compliance with established company procedures and policies as well as cGMP and all related regulatory agencies. You will need to embody the company vision and values. Additional responsibilities of this role may include:
- Performing product inspections, line clearances, facility inspections, and general product observation
- Performing Quality review of executed produciton records and material lot files
- Identify quality events and assist with associated investigations
- Create, revise, review, and approve controlled documentation
- Log and monitor data and assist with uploading documentation into shared drives
- Support the client audits and regulatory inspections
- Performs other Quality Assurance related duties and projects as assigned
- Constantly sitting and reaching to use computers and other office equipment
- Constantly viewing objects at close and distant ranges
- Frequent communication with others
The employee frequently works in a professional office environment with computer equipment and at times within a manufacturing and laboratory environment with machinery, tools, and moderate amounts of noise and activity. Employees may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct off-shift, weekend, and overtime duties may be needed as assigned by the manager of the employee.
Who You Are:
- Associates degree in a scientific discipline in Biology or Chemistry
- 5+ years of experience in a cGMP environment
- Organized and detailed oriented with strong and effective written, verbal, mathematical, and interpersonal communication skills
- Intermediate/advanced knowledge of MS Office
- Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
- Contract Manufactured Organization (CMO) experience
- Cleanroom experience
- Ability to work successfully, strategically, and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities
- Ability to obtain direction and commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity
- Ability to work independently within prescribed guidelines and effectively collaborate as part of a team
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.