Who we are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany – a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
- Oversee the CAPA system to ensure effective corrective and preventive actions are implemented to prevent reoccurrence.
- Monitors methods and processes for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Provide Quality oversight to off-shift production operations. Work closely with production staff to troubleshoot atypical events, identify an appropriate path forward, and properly document the event.
- Assist in the investigation of customer complaints through batch record review, trend analysis and CAPA evaluation
- Support the Supplier Quality Management (SQM) system through supplier evaluation (i.e. survey analysis, supplier quality audits, supplier risk assessment).
- Participate in Internal Quality Audit (IQA) program through completion of internal audits according to audit schedule. CQA Certification will be required.
- Provide back-up support for additional QA responsibilities including Document Control, Batch Release, and Change Control
- Application of statistical analysis, problem solving techniques, risk assessment, and troubleshooting
- Assist validation by reviewing protocols, execution of protocols, reviewing / writing of final reports
- Provides monthly quality indicators and improves results.
- Develops standards and procedures to provide quality guidance and methods.
- Ensures that the ISO, cGMP, and USDA guidelines, corporate policies, and site procedures are followed. Backup support for document control and batch release
- Provide training as assigned
- Lives and communicates EMD Millipore values within the organization
Who you are:
- Bachelors Degree in a Quality or Science discipline preferred (i.e. Chemistry, Biology, or Medical Technology).
- 1+ years progressive responsibility and experience in a drug manufacturing, medical device, or biologics industry preferred
- Understanding and application of Quality Systems and Engineering principles, concepts, practices and standards.
- Demonstrated experience in execution and management of CAPA and document control systems.
- Demonstrated familiarity in cGMPs, FDA regulations, and SOP development.
- Demonstrated basic computer skills and a working knowledge of basic computer software (Microsoft Office, MiniTab).
- Demonstrated verbal and written communication skills including the ability to conduct verbal presentations.
- Demonstrated success working in a team environment.
- Ability to travel by car and/or plane, typically up to 25%. Additional travel may be required based on business need.
What we offer: Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.
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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.