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Quality Assurance Associate

3 months ago

Whitestown, United States RTA US Full time
Job DescriptionJob Description

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.

Apply Today

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. 

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