Quality Assurance Specialist

The Fountain Group LLC

Louisville, KY

JOB DETAILS
SALARY
$35–$40 Per Hour
SKILLS
Distribution Operations, Distribution Services, Distribution Warehousing, Document Management, Event Management, GMP (Good Manufacturing Practices), Healthcare Quality, High School Diploma, Maintain Compliance, Manufacturing, Medical Products, Quality Assurance, Quality Management, Regulations, Transportation Planning, Zip
LOCATION
Louisville, KY
POSTED
25 days ago
The Fountain Group is currently seeking a ­­­­­­­­Quality Assurance Specialist for a prominent client of ours. This position is located in ­­Louisville, KY. Details for the position are as follows:

Pay Range: $35 - 40/hr depending on experience
Contract: 1 year with possible extension and/or conversion
Hybrid schedule. 1st shift


Job Description:
  • Manage required quality activities in the Clinical and Commercial PT distribution and in-country GMP/GDP operations owned by PT, including as applicable:
  • Regulatory readiness activities required to ensure a regulatory compliant supply of clinical and commercial material, such as the quality oversight of Artworks operations; management of GMP documents required for Launches, Variations & Renewals and management of IMP Flowcharts required to ensure compliance to the respective IND/QIMPD.
  • Quality oversight of Transportation activities including the management, resolution and Product Quality impact assessment of unplanned and planned events during transportation of clinical and commercial products.
  • Quality oversight of Clinical and Commercial PT distribution and in-country GMP/GDP
    operations, taking place at Transport providers; Warehousing & distribution centers; Partners (including External Sponsors of Clinical Trials, In- / Out-Licensing Partners, Divestment Partners and Co-Promotion Partners); Local CMOs and Laboratories contracted for in-country testing activities. Customer engagement activities, including the intake and response to Customer complaints and the design and deployment of Customer-centric solutions applicable in the distribution operations.
Qualifications:
  • High School Diploma / GED required
  • Quality experience within regulated manufacturing

If you are interested in hearing more about the position, please respond to this posting with your resume attached or contact me at 813-356-0199.

Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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About the Company

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The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/