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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
The Quality Assurance Specialist is responsible for supporting the following systems: Document Control, CAPA Program, Data Integrity, Procedure and Policy Implementation, and Internal Audits. The position is responsible for supporting the implementation and maintenance of the quality management system to ensure compliance to ISO 9001, ISO 17025 and ISO 17034, and ISO 17043. The Quality Assurance Specialist will work closely with Regulatory, Production, Quality Control, Product Management and Service to support Quality System compliance and customer needs. Responsible for leading and sponsoring improvement initiatives and goals as directed by Quality Assurance Manager and/or Site Director
- Provide support to the various teams to ensure the quality systems are maintained in accordance with procedures.
- Provide an independent and critical review of quality documents and records.
- Support goals and improvement initiatives at the site in compliance with site and corporate goals. Support rollout of local and corporate initiatives.
Directly involved in the review of open deviations and CAPA's (Corrective and Preventive Actions) . Includes following up with area managers to ensure deviations and open action items are closed in a timely manner.
Responsible for the critical review of draft validation protocols and final quality assurance review of completed validations.
Responsible for performing critical review for final product release. Ensuring documentation is in alignment with documentation practices, procedures, specifications and methods.
Responsible for creating, revising, and reviewing SOP's as needed.
Supporting established metrics and reports to track and measure the department's productivity, efficiency, and performance to quality and other goals as agreed.
Assist with customer complaint investigations and write up of such investigations to ensure customer satisfaction.
Perform internal audits per schedule and in compliance with the site's quality expectations and QMS.
Assist in preparation and hosting external audits and inspections.
Provide final QA approval of policies, procedures, protocols, specifications, suppliers, as assigned.
Work across departments and areas with other managers and staff to support the day-to-day aspects of the business, carry out company and corporate directives, meet company and corporate objectives and meet or exceed customer expectations. Who You Are:Minimum Qualifications:
- Bachelor's degree in Life Science, Leadership or Quality discipline.
- 2+ years' work experience in a GMP, GLP, or ISO environment
- 2+ years work experience in a quality environment
- Knowledge of ISO 9001, ISO 17025, ISO 17034, ISO 17043 is preferred
- Strong Knowledge of process improvement and procedure documentation preferred
- Knowledge of quality system requirements of the pharmaceutical and/or clinical industries is preferred
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.
Job Requisition ID: 215357
Career Level: C - Professional (1-3 years)
Working time model: full-time
This job has expired.