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 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: This job and many more are available through The Judge Group. Find us on the web at
About the Company:
Judge Group
The Judge Group Inc., is a leading professional services firm specializing in talent, technology, and learning solutions. We consult, staff, train, and solve. Through our work we make people and organizations better. Our services are successfully delivered through a network of more than 30 offices across the United States, Canada, and India.
The Judge Group is proud to partner with the best and brightest companies in business today, including over 60 of the Fortune 100. We serve organizations in financial services, healthcare, life sciences, insurance, government (including aerospace and defense), manufacturing, and technology and telecommunications. If you would like to learn more about The Judge Group visit or call toll free .
Company Size:
5,000 to 9,999 employees
Industry:
Computer/IT Services
Founded:
1970
Website:
