Quality Lead

Omya•Superior, WI

About The Position

The Quality Lead will be responsible for various key accountabilities including acting as a subject matter expert for lab tasks, leading training sessions for personnel, managing lab waste and inventory with third-party vendors, and overseeing scheduling for critical testing and equipment maintenance. This role also involves managing the LIMs system, reviewing production batch releases, updating SOPs, assisting with internal GMP audits, and reviewing work orders and CCPs. Additionally, the Quality Lead will provide administrative support for QSHE plans, objectives, and targets, assist in compliance and risk assessments, and maintain positive relationships with internal and external stakeholders. Quality support includes reporting, data collection, monitoring objectives, facilitating information sharing, administering management systems, and assisting with audits and investigations. The role requires strict compliance with Quality, Safety, Health, and Environment (QSHE) policies and an understanding of associated risks and legal requirements. Performance will be measured by KPIs agreed upon in the yearly Management by Objectives (MbO).

Requirements

Excellent command of both oral and written local language and English are required.
Lab experience within a Food and Pharma environment preferred, or other lab with strong GLP requirements, equivalent education or experience and training may be acceptable as well.
High level of integrity, excellent team player.
Excellent interpersonal skills and understanding of different cultures / work environments.
Good organizational skills.
Great communication skills both written and verbal.
Computer literate, including Microsoft Office.
Ability to write clear and concise documentation.
Good analytical skills.

Nice To Haves

Good command of both oral and written additional language is beneficial.

Responsibilities

Subject matter expert to the various lab tasks
Lead trainings with personnel to effectively complete tasks as it relates to the Quality Team and Lab Functions.
Lab Waste Management with 3rd Party Vendors
Lab Inventory Management.
Scheduling and Management of: TMYM and OVI Testing, Stability Testing, Calibration and PMs of Equipment, Laboratory Cleaning Schedule, ICHQ3D Testing, LIMs Subject Matter Expert, Production Batch Release Process, SOP Updates
Assist with Conducting Internal GMP Audits
Assist with Work Order, CCP, OPRP PCQI Review and Sign-off
Assist with QA Related Training for the facility
Back-up and Assist with Lab related Tasks
Any other duties or Projects as assigned
Provide administrative support in reviewing and monitoring of the QSHE plans and objectives and targets.
Provide support in reviewing and monitoring the QSHE Culture.
Assist in compliance reviews, general risk assessments and other safety assessments to support Health, Safety and Environmental management.
Maintain positive and proactive relations with managers and employees, as well as customers and regulatory agencies.
Perform other work related tasks as required as assigned.
Provide quality support: reporting, collecting data, monitoring and reviewing objectives.
Facilitate information sharing amongst sites.
Administer Management Systems Documents.
Assist in quality coordination activities needed to ensure that products meet specification and customer requirements.
Where appropriate, provide training and support for site personnel.
Assist in audits, inspections, customer complaint investigations and related activities to meet targets and objectives.
Produce and manage product information, SDS, etc.
Comply with the Quality, Safety, Health and Environment Policies.
Be aware and accustomed with the significant quality, safety/health, and environmental (QSHE) aspects/impacts associated with the work, including relevant legal/other requirements and emergency preparedness and response.