Quality Assurance Specialist (GMP)
Millipore Corporation

As a Quality Assurance Specialist at MilliporeSigma, you will ensure that all aspects of product release meet specifications in accordance with all established quality systems. You will support the maintenance, development, and improvement of GMP and/or ISO-9000 quality systems, such as auditing (internal, supplier, and customer), training, change control, complaint handling, and documentation control. You will represent the site during customer audits and regulatory inspections and stay up to date on regulatory requirements, as well as company quality policies.

Responsibilities:

Improve quality systems in both GMP and non-GMP production environmentsDrive quality improvement in multiple departmentsCommunicate the status of operations and bring critical deviations to the attention of your managerCommunicate with coworkers and interact with other departments on a regular basisComplete and have accurate work consistently within quality guidelinesTake note to details and ensure others do as wellAssist in maintaining department KPIs through on time CAPAs, Deviations, Complaints and Change ControlsAssist in compliance with Life Science and site quality policies and proceduresRepresent the site during customer and regulatory auditsPerform internal auditsAssist in the investigation of customer complaints

Who You Are:

Minimum Qualifications:

Bachelor's degree in Chemistry, Biology, or other science discipline1+ year of work experience in a GMP manufacturing or testing facility

Preferred Qualifications:

Master's degree in Chemistry, Biology, or other science discipline3-5 years of work experience in the Quality fieldExperience with quality management systems such as Trackwise, electronic document management, etc.Ability to multitask and prioritizeStrong oral and written communication skillsUnderstanding of ISO and cGMP quality standardsAbility to solve problems and coach others in problem-solving situationsComputer literacy, including Microsoft Word and Excel