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Manufacturing Compliance Specialist
A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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 Manufacturing Quality Assurance (QA) Specialist's primary role is to provide support to the cGMP operations. This position will be responsible for assisting Manufacturing, Technical Operations and QA with quality support as it relates to change control, equipment and process deviations, departmental corrective and preventative actions, and routine equipment system maintenance.
- Coordinate documentation and tasks associated with equipment and facilities:
- Change management
- New Equipment additions
- Preventative maintenance and Calibration
- Deviations and CAPAs
- Work with Manufacturing, Technical Operations, Maintenance, Engineering, Validation and Quality Assurance to ensure that change controls, deviations, CAPAs are reviewed, approved and implemented as appropriate.
- Track and report progress of quality events to management and department impacted.
- Assist with equipment, facility and process investigations, trouble-shooting including root cause analysis.
- Assist with manufacturing risk assessments.
- Maintenance of quality systems and cGMP compliance
- Ability to understand regulatory requirements such as ICH Q7
- Supports equipment commissioning, qualification and validation activities related to GMP manufacturing
- Write, review and/or assist in the development of Manufacturing, Facility or Equipment
- Assist with customer and regulatory audits
- Assist in the generation of manufacturing CAPA, deviation and change control trend reports.
- Drive continuous improvement to support customer and regulatory expectations
- Bachelor's Degree in Chemistry, Biochemistry, or other Life Science field of study preferred.
- 2+ years of experience supporting/working in a cGMP Manufacturing environment.
- 1+ additional year of experience in quality supporting related role/field would be preferred.
- Understanding of SAP and Trackwise.
- Strong computer, document management and attention to detail.
- Demonstrated ability to work within a cross-functional team.
- Effective oral and written communication skills
- Effective, disciplined, and demonstrated documentation skills
- This position will reside in an office setting. Limited travel may be required for training and auditing purposes.
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.