Quality Assurance Specialist
Millipore Corporation

Job Info

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The Quality Assurance Specialist provides compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a QA Specialist you are responsible for the implementation and maintenance of Quality Systems and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements.

Responsibilities:

include maintenance and continuous improvement of the overall Quality Program. Improve quality systems in ISO and non-GMP production environments.Drive quality improvement in multiple departments.Complete a high volume of work to meet department goals.Communicate the status of operations and bring critical deviations to the attention of your manager.Communicate with coworkers and interact with other departments on a regular basis.Complete and have accurate work consistently with quality guidelines.Assist in maintaining department KPIs through on time CAPAs, Deviations, Complaints and Change Controls.Assist in compliance with Life Science and site quality policies and procedures.Represent the site during customer and regulatory audits.Perform internal audits.Assist in the investigation of customer complaints. Contribute to Root Cause Investigations & Effectiveness Checks of Nonconforming IncidentsConduct Quality System Training.Documentation control activities include management of the electronic documentation management system, and the ability to write, review or approve Operation Procedures, Specifications, Master Manufacturing & Packaging Procedures and other controlled documents.

Who You Are:

Minimum Qualifications:

Bachelor's degree in Chemistry, Pharmacy, Chemical or Process Engineering. 3 + years' experience in industry. OR Bachelor's Degree in any discipline.5+ years applicable Quality System (i.e., ISO environment) experience in the specific QA job function as deemed appropriate by QA Management required, or An Advanced Degree in Chemistry, Biochemistry, Biology, Pharmacy or Engineering and 2+ years in industry desired.

Preferred Qualifications:

Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment.Current fine chemical industry knowledge &/or experience.Good computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.).Excellent communication (verbal & written) and customer services skills.Good writing skills and experience writing technical documentation & reports.Ability to simultaneously manage multiple tasks/priorities.Good problem-solving skills/abilities.Good time management and negotiating skills.Capacity for independent work.

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