Senior Quality Assurance Associate

The businesses of Merck KGaA, Darmstadt, Germany•Milwaukee, WI

1d•$26 - $44

About The Position

The Senior Quality Assurance Associate in Milwaukee, WI provides compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a Quality Assurance Senior Associate, you are responsible for the coordination and maintenance of Quality Systems (i.e., Document Control, Record Control, Training Program Maintenance, Deviation/CAPA, Complaints, Change Control) and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. The responsibilities include maintenance and continuous improvement of the overall Quality Program. Job duties include: Shift hours: Monday – Friday, 8:00am – 5:00pm

Requirements

Bachelor’s Degree in Chemistry, Biology, Quality Engineering, or other scientific discipline OR High School Diploma or GED with 4 + years prior experience working a Quality Assurance role

Nice To Haves

Strong computer skills, including proficiency in MS Office (Word, Excel, Access, Project, PowerPoint) and competence in learning specific application software (e.g., SAP, Trackwise).
Expertise in ISO 9001 and ISO 13485 and knowledge of global regulatory compliance (e.g., FDA, IVDR, ICH, EDQM) for biologic materials in a controlled/regulated environment, with a preference for current fine chemical industry experience.
Possess strong verbal and written communication, customer service, and problem-solving skills, with experience writing procedures and reports.
Proficiency managing multiple tasks/priorities simultaneously
Good time management and negotiating skills
Proven capacity for independent decision-making and task execution

Responsibilities

Improve quality systems in ISO production environments.
Controlled documentation activities involve managing the electronic documentation system, and the authority to write, review, or approve key documents (e.g., SOPs, Specifications, Manufacturing/Packaging Procedures).
Training management involves coordinating activities, reporting metrics, and overseeing the electronic training platform to complete a high volume of work and meet departmental goals.
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 maintaining site quality and Life Science compliance, including participation in internal audits (and potentially serving as Lead Auditor), and supporting customer complaint investigations.
Contribute to Root Cause Investigations & Effectiveness Checks of Nonconforming Incidents.
Conduct Quality System Training specific to job function.
This individual will work with various internal departments to develop, improve, and execute processes used in an ISO 9001 and ISO 13485 quality system environment.