Job Description:
Role: QA Assistant
This role is part of our Hybrid Work Model and will be based in our Cork city centre office.
Main Purpose and Objectives:
* Provide key support to the QA function within Stability Management, Material Management/Supply Chain, and QA support.
* Coordinate the Stability Program - Management including study activations, study sample inventory, equipment monitoring, manage stability samples, approval of Stability Study Reports.
* Responsible for packaging/preparation of products in the laboratory.
* Responsible for quality-related matters specific to the area of responsibility, including any deviations and associated investigations.
* Generate Certificates of Analysis/Conformance to support shipping requirements.
* QA review of laboratory notebooks and logs.
* Assist with reconciliation of laboratory notebooks as required.
Key Responsibilities:
* Site stability program coordination.
* Working with the Annual Stability Sampling Plans ensuring oversight of stability sample management.
* Participating member of a New Product Introduction team on product stability requirements.
* Study management for Stability program lots, study timepoint pulls, completion of Stability Studies, flagging batch status, registering parent lots, and completing study activations.
* Development of Study Lot Details and creation of graphics on Darwin Stability Program.
* Study completion and notification to management for final approval.
* Monitoring stability units - alarm response, review of temperature/humidity trends to ensure alarm response/deviation are complete.
Materials Management/Supply Chain:
* Creation of Certificates of Analysis and Certificates of Compliance for weekly Shipping using various systems and reports, working with Shipping schedule.
* Supporting QA team to ensure Non-Routine Certificate of Analysis are maintained.
* Perform COA compliance checks for consumables and raw materials.
Requirements:
* Education: Hons BSc, MSc in Chemistry, Engineering, Quality, or related discipline, with a minimum of 2 years relevant experience.
* Language Requirements: Proficient English speaker.
* System experience an advantage: Veeva Vault, Trackwise, Darwin, SuccessFactors, MS Word, Excel, Teams.
Join Our Team:
We're seeking a highly skilled QA Assistant to play a crucial role in delivering customized Business Process Outsourcing (BPO) solutions. As a valued team member, you'll contribute to our legacy of success in providing outsourced solutions for Fortune 500 companies.
Equal Opportunity Employer:
At Covalen, we champion diversity and equality, anchoring our workplace cultures and creative minds. We recognize the collective strength found in diverse backgrounds, skills, and experiences of our team members.