Quality Lead

Omya•Superior, AZ

About The Position

The Quality Lead will be responsible for various laboratory tasks, including leading training sessions for personnel, managing lab waste with third-party vendors, and overseeing lab inventory. This role involves scheduling and managing TMYM and OVI testing, stability testing, equipment calibration and preventative maintenance, and laboratory cleaning. The Quality Lead will also be involved in ICHQ3D testing, acting as a Subject Matter Expert for the Laboratory Information Management System (LIMs), and managing the production batch release process. Responsibilities include updating Standard Operating Procedures (SOPs), assisting with internal GMP audits, reviewing and signing off on Work Orders, CCPs, OPRPs, and PCQIs, and providing QA-related training for the facility. The role also requires backup support for lab-related tasks and other assigned duties or projects. Additionally, the Quality Lead will provide administrative support by reviewing and monitoring Quality, Safety, Health, and Environment (QSHE) plans, objectives, and targets, and supporting the review of QSHE culture. This includes assisting with compliance reviews, general risk assessments, and other safety assessments to support Health, Safety, and Environmental management. Maintaining positive and proactive relationships with managers, employees, customers, and regulatory agencies is also a key part of the role, along with performing other assigned work-related tasks. The Quality Lead will provide quality support through reporting, data collection, monitoring, and reviewing objectives, facilitating information sharing among sites, and administering Management Systems Documents. This role assists in quality coordination activities to ensure products meet specifications and customer requirements, providing training and support to site personnel where appropriate. It also involves assisting in audits, inspections, customer complaint investigations, and related activities to meet targets and objectives, as well as producing and managing product information, SDS, etc. Compliance with Quality, Safety, Health, and Environment (QSHE) policies is mandatory, requiring awareness of significant QSHE aspects/impacts, legal/other requirements, and emergency preparedness. The role has a solid line reporting to the QSHE Supervisor.

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.