Website The Fountain Group LLC
The Fountain Group LLC
Company : The Fountain Group LLC
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 (phone number removed).
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
#ZIP
#LI-OL1