PLC Quality Associate
2 months ago
-6 month contract, pay $23/hr
SHIFT: This would be regular business hours for the moment, but at a later undetermined time would transition to a 2nd shift.
Current work hours 6am-3:30pm. 2nd shift hours will likely be 2:30pm-11pm.
RESPONSIBILITIES
List current duties and responsibilities
1. Responsible for handling of unsuitable units. Generates reports regarding disposition of unsuitable units. Handles
appropriately per specification.
2. Control shipments of units designated for destruction. Handle shipments and products per cGMP requirements.
Maintain proof of destruction for these units.
3. Review and release outgoing plasma shipments. Close inbound shipments when all product is received in LOGIC.
4. Use LOGIC functions appropriately for all Quality related actions.
5. Perform periodic temperature related activities as dictated by the appropriate SOPs. These may include daily
temperature checks, periodic calibrations and validations.
6. Perform other duties such as safety checks, unit relabeling, pest management service reviews…
7. Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply
with company and regulatory standards.
8. Coordinates and monitors the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements.
9. Handle special requests including lab requests, third party shipments and non-injectable shipments.
10. Communicate clearly both verbally and in written form.
11. Follow all Standard Operating Procedures (SOPs), company policies and procedures.
12. Identify and report issues, non-conformities and actions that may compromise product safety, quality, identity
potency or purity to PLC Management in a timely manner. Investigate and document episode using the Track wise
software system.
13. Perform other duties, as assigned, to support business needs.
*The freezers are kept at -25°C or colder and cold room at 5°C. The employee will be exposed for short periods of time to these temperatures when retrieving material.
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