Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
Support GMP production by performing batch record issuance, review, correction, release, and retention as well as periodic assessments for production lab compliance. Support the site’s maintenance, development and improvement of Quality Systems, such as training, CAPA, deviation, change control, and documentation control. Ensure that all aspects of GMP product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems. Supports the site’s compliance activities through regulatory recordkeeping and reporting. Specific job duties include:
Process ImprovementActively participate in the development, implementation, and improvement of Quality Systems.Routinely support and recommend ongoing process improvements within department, ensuring efficient and value-added processes.Lead and participate in work with Production, QC, Procurement, Packaging, Maintenance, Customer Service and Marketing to resolve issues and failures with site products and equipment. Work closely with the site departments to implement process changes based on investigation conclusion.Oversee Trackwise system and aid when necessary to end users to ensure appropriate entries are made and resolution is achieved in a timely manner.When necessary present various quality system training topics to site personnel.Identify opportunities for process improvement.Ensure acceptable product and process consistencyServe as a primary reviewer of executed GMP batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release. Report all process deviations and/or laboratory OOS results. Investigate QA-pertinent process anomalies.Assist in writing, reviewing or approving GMP Operating Procedures, Validation Protocols/Reports, Master Production Records, Specifications and other documents for GMP products.Supports the site’s Compliance activitiesEnsure reports are complete and accurate for HR4You, Trackwise, and Mango and site quality metrics.Ensure appropriate site Quality Assurance personnel are trained as backup for systems role.Facilitate training of other site personnel as required.Follow all safety and quality requirements to complete assigned work.Remains up to date on regulatory requirements, as well as company and corporate quality policies through means such as intercompany meetings, webinars, email services etc.Maintain, clean, and keep safe all work areas and equipment.Maintain personal protective equipment.Complete the volume of work required to meet departmental goals and meet deadlines.Immediately report any situation that could compromise safety or quality.Exemplary attendance and adherence to schedule.Communicate the status of operations and bring critical deviations to the attention of Quality Manager or Site Director in the absence of the Quality Manager.Provide complete and accurate records consistent with quality guidelines.Develop and promote cross functional partnerships with other departments.Ability to serve on committees to improve department, site or company performance. Committees may focus on safety, quality, inventory, output, costs, etc.In compliance with change control procedures, improve processes through application of industry knowledge, experience, and principles.Miscellaneous duties and tasks as assigned by Quality Manager.
Who You Are
Minimum Qualifications:
Bachelor’s Degree in Chemistry, Biology, or other Life Science Discipline2+ years of experience in an independent lab within a manufacturing or research environment
Preferred Qualifications:
Experience in high volume and high data environmentknowledge of chemistry with an emphasis on analytical or organic chemistryWorking knowledge of cGMP, cGLP, cGDP, and ISO 9001 proceduresKnowledge of ISO and GMP quality standardsProficient in Microsoft Office Suite
RSREMD
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html