Quality Control Operations Specialist

Merck•Verona, WI

1d•Onsite

About The Position

The Operations Specialist, Quality Control position supports planning, execution, and governance for quality systems projects in the Quality Control (QC) department. This position will have an understanding of the analytical workflow and instrumentation (HPLC, GC, KF, DSC, TGA, IR, MS, NMR, LC-MS and ICP-MS among other tests) in a QC lab in order to be able to critically evaluate, coordinate, and implement changes and process improvements. This position demonstrates the ability to work on, and solve problems independently with minimal guidance. This position will participate in duties and actions that support the QC functional areas to maintain an audit ready state and participate in responses to audit findings. This position is also responsible for maintaining project timing/costs and interacting with internal/external clients to assure project goals are met. Other responsibilities include maintaining a clean and safe working environment, drafting and reviewing departmental documents, and participating in data integrity initiatives. The Operations Specialist, Quality Control position, like all positions at MilliporeSigma, have a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.

Requirements

Bachelor’s Degree in Chemistry, Biology, or other Life Science discipline.
5+ years in cGMP analytical laboratory environment.

Nice To Haves

Master’s Degree in Chemistry, Biology, or other Life Science discipline.
Work cross-functionally and to develop and maintain strong business partner relationships.
Work with teams that work across various shift schedules that cover 24 hours/7 days.
Manage multiple projects simultaneously with minimal supervision.
Proficient with Microsoft Office Product (Outlook, Word, Excel, and PowerPoint).

Responsibilities

Drive continuous improvement through leading cross function teams to implement system improvements, Respond to new regulations, address evolving business needs, and enhance training for QC functional areas.
Manage the full lifecycle of deviations, investigations, CAPAs's, audit responses, and change controls within QC, ensuring timely closure, robust root cause analysis, and effective preventive actions.
Assist in identifying, maintaining , and reporting functional KPIs to site management, enabling data-driven decision making and performance tracking.
Participate in data integrity initiatives and processes related to QC functional areas.
Work cross-functionally to support and expand digitization operations within QC (such as: STARe, Ommnis, Diffracto suite, Chromeleon, LIMS, and other software systems).
Assist in drafting and reviewing of QC-related SOP's, technical reports, user requirements, and other documentation using the principles of ALCOA+.
Represent QC interdepartmentally on QC projects, facilitating efficient and collaborative interactions with internal and external stakeholders.
Other duties as assigned.
Adhere to the GMP requirements defined within 21 CFR parts 210 &211, 820, ICH Q7, Safety standards set under ISO 14001 & 45001.