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Quality Assurance Associate
1 month ago
What are we looking for in our Quality Assurance Associate?
Russell Tobin's client, a biotechnology company is seeking a Quality Assurance Associate in Whitestown, IN
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.
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Employment Type: Contract/Onsite
Location: Whitestown, IN
Pay rate: $64-$75/hr, DOE
Responsibilities:
- Responsible for handling of unsuitable units. Applying of label/overlays on product.
- 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.
- Communicate clearly both verbally and in written form to others within CSL Plasma and outside vendors.
- Follow all Standard Operating Procedures (SOPs), company policies and procedures.
- 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.
- Perform other duties, as assigned, to support business needs.
- Operating of a forklift (CSL will train)
Requirements:
- Computer Science
- Experience in or knowledge of Python, Celery, Go, Elasticsearch, PostgreSQL, SaltStack, Flask, Git, React, Elixir.
- Deep understanding and knowledge of virtualization (libvirt, KVM, Xenserver).
- Strong programming skills including software engineering methodologies and best practices.
- REST/API development.
- Strong experience with Python or other scripting languages.
- Experience working in a Linux development environment.
- Strong experience with relational databases, and specifically MySQL, Elasticsearch, Redis.
- Excellent HTML, CSS and JavaScript skills. Experience in consuming RESTful APIs.
- Java Rest React NoSQL db AWS Cloud Tech
- 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
Benefits that Russell Tobin offers:
Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.
#CB
Rate/Salary: $64-$75/hr, DOE
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