Quality Assurance Inspector

2 weeks ago


Somerset, United States The Fountain Group Full time
Job DescriptionJob Description

Pay: $36-$41/HR

 

MON-FRI 8:30AM - 5PM.

Job Description:

Quality Operational Specialist supporting manufacturing department quality-related activities. Candidate should have prior GMP inspection and documentation quality review experience within a pharmaceutical manufacturing facility or equivalent. Candidate must be detail-oriented in a fast-paced multi-task environment with good oral and written communication skills and can interact with all levels of management and other supporting departments.

  • Conduct audits of Pharmaceutical Development Manufacturing Facility to ensure compliance with CGMP, DEA, Corporate and pharmaceutical development SOPs
  • Perform QA Room Releases, line clearances, equipment releases and AQL inspections as required.
  • Provide Quality Floor supports during batch manufacturing by performing routine Quality auditing.
  • Provide QA support to Manufacturing for clinical and commercial batches
  • Audit of executed Batch Records for compliance with CGMP and provide customer audit responses as required
  • Audit of raw materials, facility logs, release data.
  • Interdepartmental communication for obtaining information and audit corrections
  • Comply with and ensure compliance of the department with Health, Safety and Environmental responsibilities
  • Assist with batch investigations as required
  • Able to work over the weekend and stay outside business hours if required as direct by the department manager.
  • Assist other duties assigned by manager to support the department and business.

 

Qualifications:

  • Education or Equivalent Requirements:
  • High school diploma or equivalent (GED) with 8+ years of relevant experience within the pharma industry in Quality Assurance, Compliance, or Manufacturing.

 

Knowledge/Skills Requirements:

  • Good understanding of compliance regulations and audit techniques.
  • Thorough knowledge of cGMPs, ability to evaluate facilities records, processes, procedures and practices for conformance to these requirements.
  • Full understanding of FDA, CGMP, and DEA regulations pertaining to Pharmaceutical manufacturing
Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.

Browse our website below for additional information on our company.

The Fountain Group

4505 Woodland Corporate Blvd, Tampa, FL 33614
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r
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Browse our website below for additional information on our company.\r
\r
The Fountain Group\r
\r
4505 Woodland Corporate Blvd, Tampa, FL 33614\r
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”

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