Job Title: QC Analyst
A senior position for an experienced Quality Control (QC) professional to lead sample management activities across the site, including sample distribution, LIMS logging, and shipment receipt.
Tech Requirements:
* GMP experience in a GMP environment with sampling process & handling.
* Ability to self-schedule and coordinate schedules based on team priorities.
* Experience using electronic systems such as LIMS or ERPS (SAP).
Duties:
1. Execute sample management activities: sample distribution, LIMS logging, shipment receipt.
2. Perform Stability Program related activities: pulling stability samples, study initiations.
3. Create/own and approve protocols, sample plans, SOPs, training manuals.
4. Perform SAP, LIMS, and CIMS functions/transactions within sample management remit.
5. Out-of-hours responder for sample management equipment (fridges/freezers/incubators).
6. Responsible for own training and safety compliance.
7. Sample shipments and temperature monitoring activities.
8. LIMS data coordination of commercial and import batches.
9. Management and maintenance of Site Inventory of Reference Standards, Assay Controls, Training, and Verification samples.
10. QC Representative for NPI activities and routine Product meetings as required.
Key Responsibilities:
* Liaise with site Planning, Manufacturing, and Inspection regarding manufacturing schedule and required QC testing.
* Liaise with Stability Product Representatives and Product Quality Leads as required.
* Perform routine sample management tasks as per procedures.
* Work across diverse areas within QC with technical flexibility.
* Plan and perform multiple, complex routine/non-routine tasks with efficiency and accuracy.
* Report, evaluate, backup/archive, trend, and approve data.
* Troubleshoot, solve problems, and communicate with stakeholders.
* Initiate and/or implement changes in controlled documents and equipment.
* Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
* Operate and maintain GMP equipment, including responding and management of GMP alarms.
* Introduce new techniques/Processes to the area, where appropriate.
* Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
* LIMS data coordination of commercial and import testing lots where applicable.
* LIMS lot logging for manufactured lots.
* Provide technical guidance and contribute to regulatory filings.
* Represent the department/organization on various teams as required.
* Train others.
* Interact with outside resources.
* Perform general housekeeping in all sample management areas in line with 5S.
This is a senior position, requiring approximately 3-5 years of experience in a similar level role. The successful candidate will have strong technical skills, excellent communication, and problem-solving abilities, as well as the ability to work independently with minimal supervision.