PLC Quality Associate
3750 Perry Blvd Whitestown, IN 46075 US
Job Description
*Depending on experience
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 to others within CSL 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.
JOB SPECIFICATIONS
Provide minimum hiring requirements, specialized knowledge, and other considerations required
Education? High School diploma or GED equivalent, combination of education, training and experience
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
? Establish solid working relationships to interface with and support senior management, third parties
and other positions and circumstances within the organization
? 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
? Learn new processes and quickly engage in assignments to drive for action
? Preferred 1 to 3 years of experience in plasma or plasma related field
? Knowledge of cGMPs as they relate to the plasma industryÂ
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