Quality Specialist 3 - 2nd shift

Your Role:

At MilliporeSigma, as the Quality Specialist 3 – 2nd shift, you will perform a variety of tasks within the Quality Assurance department including providing real-time Quality expertise on the floor, and ensuring GMP standards are met, verify compliance with standard operating procedures, conducting audits and review / approval of various types of regulated documentation and support integration of a Quality approach in all our processes. Solves problems of varying complexity independently by identifying and selecting solutions and by analyzing information. 

• Shift – Monday-Friday 2:00pm-10:30pm
• Provide active Quality on the Floor (QotF) support to laboratory operations - by being present on the floor e.g. observing critical processes, performing visual inspection, scheduling/assay documents, and offering support in the flow of work
• Review and provide feedback on documents such as Laboratory batch Records, logbooks, and other GMP data/ records while being present on the floor
• Lead and apply the highest standards of Data Integrity / Good Documentation Practices in our processes e.g. supporting document completeness, accuracy, and compliance (including online review of coordinated LIMS, and CofA generation or similar)
• Assist in timely resolution for quality-related issues and compliance concerns as a first responder If any issues or concerns arise, report them immediately to the Quality Assurance and/or Operations teams
• Perform daily quality assessments/checks of classified/ non-classified areas to detect errors or deficiencies. Lead by example, always demonstrate a Quality approach
• Contribute to self-inspection and process audits in laboratory operations and work closely with operations partners and GEMBA colleagues
• Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records
• Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis
• Review and approve validation files for assays
• Write, review, and approve documents such as Standard Operating Procedures and Work Instructions
• Review and approve deviations/OOS records of varying impact and criticality and approve change control (GCC) records
• Serve as liaison to Quality Culture initiatives and demonstrate Quality Culture in their daily work
• Prepare technical plans, reports, and protocols as needed
• Partner with other functions and departments e.g. project management, facilities, Inventory management, Test Article Receipt to alert them to Quality events
• Assist with quality improvement initiatives 

Who You Are 

Minimum Qualifications:

• Bachelor Degree in scientific field (e.g., Biology, Chemistry, Biochemistry, etc.)
• 4+ years of experience in Quality field within a GxP environment

Preferred Qualifications:

• 2+ years in quality laboratory and/or experience as a manufacturing or laboratory floor inspector or technician in a fast-paced environment
• Acts ethically and ensures quality of own work and that of others
• Open-minded, flexible and works with agility
• Takes responsibility for ensuring that turnaround times are met
• Works with cross-functional teams and builds networks within QA and Operations departments
• Collaborates with various teams to identify and implement improvements
• Willing to embrace and implement change on a global scale
• Expert knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity)
• Knowledge of laboratory operations, including equipment, materials, work flow, etc.
• Excellent communication, facilitation, and conflict resolution skills

$70,500 - $118,300

Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors.  This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.