PLC Quality Associate
The Judge Group Inc.

Location: Whitestown, IN
Salary: Depends on Experience
Description: Our client is currently seeking a PLC Quality Associate

For immediate consideration please email your resume to Kristen Hawkins
khawkins@judge.com

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 such as shipment release and closing, temperature monitoring, cGMP training and special product requests.

This job will have the following responsibilities:

• Responsible for handling of unsuitable units.
• Generates reports regarding disposition of unsuitable units.
• Handles appropriately per specification.
• Control shipments of units designated for destruction. Handle shipments and products per cGMP requirements. Maintain proof of destruction for these units.
• Review and release outgoing plasma shipments. Close inbound shipments when all product is received in LOGIC.
• Use LOGIC functions appropriately for all Quality related actions.
• Perform periodic temperature related activities as dictated by the appropriate SOPs. These may include daily temperature checks, periodic calibrations and validations.
• Perform other duties such as safety checks, unit relabeling, pest management service reviews
• Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.
• 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.
• Handle special requests including lab requests, third party shipments and non-injectable shipments.

"Extreme temperatures" this includes that warehouse has a 2 walk in freezers and a cold room. 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.

Hours: 6am-3:30pm.
Length of Contract: 6 months

Qualifications & Requirements:

• High School diploma or GED equivalent, combination of education, training and experience
• Minimum 1 year experience in related industry within a Regulatory Affairs or QA capacity preferred • Understand regulatory standards, various local, state and federal laws that apply to the business and where to find information on standards and interpretations.
• Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives.
• Strong customer service orientation with flexibility and adaptability to work as a member of the team.
• Intermediate to strong working knowledge of Microsoft Office products.
• Proven ability to work in a fast paced, dynamic environment.
• Preferred 1 to 3 years of experience in plasma or plasma related field.
• Knowledge of cGMPs as they relate to the plasma industry.
  

WORKING CONDITIONS:

* 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

* May be required to work overtime and extended hours.

* Frequent standing, bending, twisting and walking.

* Ability to lift or carry up to 50 lbs.

* Frequently required to wear personal protective equipment.

* Occasionally exposed to blood borne pathogens and extreme temperatures

Contact: khawkins@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.