A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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.
Your Role: Perform Quality Control activities in support of GMP products including routine testing and peer review of raw materials, intermediate and final products, and stability samples.
- Total sales revenue supported:
- Total number of employees supervised (in organization): N/A
- Number of locations responsible for: 1
- Total operating/department budget: Varies
- Total capital expenditures: Varies
ESSENTIAL JOB FUNCTIONS
- Safely perform operations to meet quality expectations.
- Ensure quality through adherence to GMP requirements. Assure adequately trained to perform tasks/assignments. Perform routine assays in accordance to applicable GMP requirements, processes and/or unit operations. Clean-up equipment and working areas during and after operations.
- Complete the volume of work required to achieve group/departmental goals and meet deadlines.
- Contribute to support functions of the lab (e.g., maintain equipment, prepare reagents, restock lab supplies, waste disposal).
- Communicate the status of operations and bring deviations to the attention of supervisor.
- Provide complete and accurate records consistent with quality guidelines and GDP requirements.
- Interface across departments
- Participate as needed in quality audits.
- Accurately perform procedure independently.
- Perform complex assays and processes requiring a higher level of skill and knowledge
- Identify problems and limitations of analysis.
- Perform advanced troubleshooting utilizing technical knowledge and theory.
- Review of final assays and procedures.
- Interface with external customers.
- Design basic experiments, evaluate data and draw conclusions.
- Provide logical explanations and potential solutions.
- Write and modify procedures consistent with quality guidelines and review other procedures as requested.
- Conduct training on complex analytical procedures
- In compliance with change control procedures, improve processes through application of scientific knowledge, experience, and principles.
- Identify opportunities for process improvement.
- Participate in process improvements under the guidance of a Supervisor.
- Develop improvement ideas, review impact of changes and document all work.
- Take the necessary action to resolve any unsafe conditions.
- Develop efficient processes/procedure for existing and new product introduction, assays, technologies, instrumentation and software.
- Train personnel and act as a technical consultant as needed. Perform and interpret analytical data.
- Supply information based on experience and knowledge.
- Train personnel on instruments/equipment and techniques by supplying sufficient demonstration, theory and support.
- Provide technical support to personnel to assist in problem solving.
- Provide technical support to cross-functional teams.
Who You Are:
- BS/BA or MS degree in chemistry, biochemistry, biology, chemical engineering or related life science.
- > 3 years of GMP experience in pharmaceutical, biopharmaceutical or similar industry desired
- Knowledge of GMP Quality standards (ICH Q7, 21CFR 210/211/820, EU Annex)
- Laboratory and analytical skills.
- Knowledge in chemistry or biochemistry, math and general science.
- Familiar with laboratory instruments and production equipment.
- Analytical techniques and equipment.
- Safe chemical handling methods.
- Communication skills, oral and written.
- Computer skills.
- Troubleshooting skills.
- Interpersonal skills.
- Organizational skills.
ADDITIONAL LOCAL NEEDS
Chemical environment-Must be able to perform tasks while wearing personal protective equipment such as respirator or chemical protective clothing for extended periods.
May require occasional lifting and pushing of up to 40 pounds.
May require shift work.
Cherokee Facility in St. Louis
- FDA Registered facility
- Bioconjugation, Protein purification, Bio-organic, and Biological buffer Production, QC testing and Packaging
Broadway Facility in St. Louis
- FDA Registered facility
- Sterile Liquid Cell Culture media and Additives Production, QC testing, and Packaging
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 come2emd.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 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.