Quality Assurance Associate
3750 Perry Boulevard Whitestown, IN 46075 US
Job Description
*Depending on experience
GENERAL SUMMARY:
This position is primarily responsible for the identification, removal and destruction of all plasma units deemed unacceptable. The associate is responsible for day-to-day activities at the PLC such as shipment release and closing, temperature monitoring, cGMP training and special product requests.
RESPONSIBILITIES:
1 Responsible for handling of unsuitable units. Applying of label/overlays on product. 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 to others within  Plasma and outside vendors.
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.
14 Operating of a forklift (please note, this is not required if suppliers are able to support forklift)
Working Conditions (physical & mental requirements):
• Ability to make decisions which have significant impact on the immediate work unit and monitor impact outside immediate work unit
• Ability to compose letters, outlines, memorandum and basic reports and/or to orally communicate technical information
• Influences or negotiates with internal contacts where conflicting objects may inhibit reaching a solution
• Ability to understand, remember and apply oral and/or written instructions or other information
• May be required to work overtime and extended hours
• Frequent standing, bending, twisting and walking
• Ability to lift or carry up to 50 lbs.
• Fast paced environment with frequent interruptions
• Frequently required to wear personal protective equipment
• Occasionally exposed to blood borne pathogens and extreme temperatures
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