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Analyst 2 - Quality Assurance

The Fountain Group LLC

Shepherdsville, KY

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JOB DETAILS
SALARY
$40–$45 Per Hour
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Budgeting, Change Control, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Distribution Channel, Distribution Operations, Distribution Services, External Audit, Internal Audit, Maintain Compliance, Medical Equipment, Process Management, Product Reviews, Product Support, Product/Service Launch, Quality Assurance, Quality Management, Receiving Inspection, Records Management, Risk, SAP, Standard Operating Procedures (SOP), Standards Development, Supply Chain, Time Management, Training/Teaching, Warehousing, Willing to Travel
LOCATION
Shepherdsville, KY
POSTED
30+ days ago
Hi,
My name is Avery , and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Quality Assurance Analyst for a prominent client of ours. This position is located in Shepherdsville, KY or Somerset, NJDetails of the position are as follows: 
 
Job Description: 
  • Pay: $40-45/hr to Start!!
  • 12-month assignment, possibility for extension or conversion based on performance and budget.
  • Mon – Fri (10% Travel)
  • The position will mainly be responsible for quality and compliance product reviewing process, including, but not limited to receiving inspection activities such as review of temperature monitoring devices and systematic transactions in Warehouse Management System and/or SAP
  • The position will monitor and follow Quarantine/Hold/Stop-Ship/Recall processes and notices
  • The position will perform product refusal process activities, including inspection and disposition.
  • The position will serve as a single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.
  • The position will be responsible for the adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and Quality Management Systems
  • The position will be responsible for adhering to the Records Management and Retention process
  • The position will support internal and external audits.
  • The position will support, plan, and coordinate quality and compliance programs designed to ensure effective and consistent processes with established standards by performing duties personally.
  • The position will provide quality and compliance oversight for execution of protocols
  • The position will develop and review Standard Operating Procedures, Work Instructions and other documents as needed.
  • The position will support New Product Launch activities at the Distribution Center including Mater Dara (sIDMa) set up
  • The position will ensure compliance and evaluate the overall compliance risk and recommend corrective actions
  • The position will provide compliance oversight for the end-to-end clinical supply chain processes and provide compliance oversight for the end to end re-pack-re-label processes
  • The position will support 24/7 operations of the distribution center and provide training to new hires
 
Qualifications: 
  • High School Diploma or Equivalent Required!
  • 2+ years of experience in a regulated industry Required!
  • Quality and Compliance experience in the Medical Device, Pharmaceutical, or Consumer products industry and experience in distribution Preferred!
  • Experience with Warehouse Management System and SAP Preferred!
  • Experience with Quality Management Systems such as COMET Preferred!
  • Experience with temperature control Preferred!
 
If you are interested in hearing more about the position, please respond to this post with your resume attached or contact me at 813.321.6334 
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days. 
 
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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/