Quality Manager


Job ID:

6368

Job Location:

Lenexa, KS


Job Requirements

Minimum Education: College Degree
At least 2 years expereience in a Quality Assurance role
Experience having hosted or participated in FDA inspections or be able to demonstrate knowledge of how to host an FDA inspection
Excellent attention to detail and highly organised
Good knowledge of Quality Management systems
Knowledge of current regulatory requirements for warehousing of pharmaceuticals in the USA
Experience in the use of Microsoft Word and Excel

Job Description

Job Overview
Reporting to the Deputy Director of QA in the UK, and based within the Corporate Quality Department, the successful candidate will be responsible for handling all elements of the Quality Management system and control of finished product in our Lenexa warehouse. This position will have neither direct nor indirect reports.

Main Activities/Tasks
The main duties of this role will include but will not be limited to the following:

- Status Labelling of product e.g. On-test to Passed for Dispatch
- Completing quality checks on incoming product deliveries and quality checks on orders set up for dispatch
- Ensure segregation of different status material is enforced
- Download and assess loggers measuring temperature and humidity in the warehouse and make determinations on suitability of product
- Ensure H&S reviews are completed
- Oversee training. Keeping staff in the warehouse abreast of local authority and FDA requirements
- Conduct quality audits of sub-contractors as required
- Initiate and maintain Quality & Technical Agreements with sub-contractors as required
- Communicate with customers as and when required e.g. in relation to returns, complaints, recalls
- Review and assess complaints and returned goods received from customers, liaising with UK headquarters as required
- QA management of documentation SOPs and etc.
- Maintain calibration data and daily check documentation from Temp sensors
- Quality investigations from identified deficiencies
- Implementing and monitoring progress of Corrective and Preventative Actions
- Provide QA oversight for all US supply chain activities
- Continuous improvement of the site through self inspection
- Lead and perform recalls e.g. reconciliation of product returns, effectiveness checks final reports
Host local regulatory authority (FDA) inspections, act as guide for inspector, draw up responses to any inspection observations.


Industry:

Industry

Type:

Quality Assurance

Earnings:

$60,000 - 69,000

Minimum Years Experience:

1 to 5

Travel:

0%

Minimum Degree:

College Courses

# of Openings:

1

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