Quality System Specialist

What’s the Role?

The Quality System Specialist is responsible for supporting Quality Assurance functions, primarily focused on establishing and maintaining processes to ensure compliance with internal and external requirements and regulations.

What the role does:

· Manages and designs forms, workflows, applications, and analytic dashboards in the Quality Management System (QMS) Cloudtheapp.

· Assists in QA management of employee accounts in the QMS

· Leads routine meetings with the QMS developer to discuss system modifications, upgrades, and issues.

· Trains employees on how to use the QMS while monitoring training completions

· Conducts annual GMP training

· Manages and monitors document control including new creation, reviews, and updates of SOPs.

· Leads weekly Change Management meeting; initiating, documenting, and completing changes in the QMS

· Creates new and revised master specification, label, and similar records

· Leads Internal Audit program

· Supports biannual Management Review for a quality assessment of the company

· Acts as a backup for the QA Product and Safety Specialist by reviewing, approving, and uploading Certificates of Analyses (CofAs) and other internal analytical testing reports

· Reviews batch records received from the contract manufacturers for accuracy and completeness

· Assists with customer feedback investigations, compiling information from relevant departments to solve issues.

· Writes and/or reviews deviations, CAPAs, and other quality records

What we need from you:

· Bachelor’s degree in a scientific discipline or engineering

· 2 or more years of relevant QA experience.

· Experience with electronic Quality Management Systems and the change control process.

· Internal Audit training strongly preferred

· Six Sigma training is a plus

Who we are:

We are an equal opportunity employer that operates with an emphasis that People Matter. We respect and will consider every and all kinds of people regardless of race, color, religion, sex, sexual orientation, gender identity, age, natural origin, protected veteran status, disability, or any other factors prohibited by law or humanity.