Quality Assurance Specialist

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.

Your Role:

The Technician, Quality Control 3 is responsible for support of the QC department through reagent inventory management, glassware cleaning, pipette verifications, environmental monitoring testing, routine raw material testing or bulk sampling, ordering supplies, cleaning verification swabbing, and general lab audit readiness. Testing may include visual appearance, IR, Karl Fischer (KF) analysis, gas chromatography (GC), automatic titration, and other compendial testing or instrumentation techniques. Additional responsibilities include peer review of documentation, report/deviation/OOS writing, support of documentation/organization (scanning/filing/copying) activities for QC or other departments, writing or revising standard operating procedures or other documentation, and participation in process improvement initiatives. The Technician, Quality Control 3 position, like all positions at Millipore Sigma, will have a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.

• Performing environmental monitoring testing and write trend reports.
• Performing cleaning verification swabbing or visual inspections.
• Sampling and analytically test raw materials or other analyses as assigned. Testing may involve visual appearance, IR, KF, GC, automatic titration, and other tests and instruments.
• Performing pipette verifications and ship out pipettes for calibration.
• Printing, filing, scanning, copying, and organizing quality documents.
• Performing data entry activities in appropriate document control, inventory control software, etc.
• Working in accordance with current GMP practices demonstrating proper safety and housekeeping practices.
• Maintaining accurate and concise records, as well as assisting with peer review of documentation for accuracy.
• May provide or request documents via email or phone transactions to customers or vendors.
• Performing annual retain or reagent inventory audits.
• Maintaining exemplary attendance and adherence to schedule.
• Working on problems of moderate scope and exercise judgment within defined procedures and practices to determine appropriate action. Obtaining assistance from supervisor or more experienced staff when needed.
• Writing and revising SOPs including raw material specifications.
• Working cooperatively within the QC department and with other departments to achieve project goals.
• Working in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable.
• Working in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.
• Participating in OOS or deviation investigations via testing and good documentation/writing.
• Maintaining laboratory in an audit-ready state which may include ordering reagents or supplies, cleaning glassware, waste management, dusting, vacuuming, and mopping laboratory areas.
• Working near moving mechanical parts. Frequently wearing personal protective equipment "PPE" to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles.
• Regularly using phones, computers, computer monitors, and all office/laboratory equipment.
• Typing at a computer keyboard and reading CRTs/computer monitors.
• Miscellaneous duties and tasks as assigned

Physical Attributes:

• Regularly sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time.
• Occasionally lift and/or move up to 25 pounds unassisted and be capable of pushing and pulling heavy materials to complete assignments. May lift more poundage with assistance.
• Speaking, hearing, tasting, and smelling.
• Using close vision, distance vision, color vision, peripheral vision, depth vision, and the adjusting focus.
• Working with highly potent/hazardous materials requiring the use of proper PPE, which could include half/full face respirators.

Who You Are:

Minimum Qualifications:

• High School Diploma or GED

Preferred Qualifications:

• Associate Degree with some chemistry or related biological sciences courses.
• Excellent written and verbal communication skills, technical writing skills, as well as excellent documentation practices.
• Leadership skills and collaboration within a team environment and in analytical testing labs with hazardous and toxic chemicals.

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!

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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.