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Senior Quality Control Analyst

$45 - $86 per hour

The Fountain Group

Details for the position are as follows:
  • 6-month contract to start
  • Rate: $45-86 an hour depending on experience level
  • Location: Social Circle, GA -100% onsite
Job Description:
  • Perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeia standards.
  • Author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies.
  • Design and coordinate analytical method onboarding activities, including execution planning, training, and documentation.
  • Lead and manage the qualification of critical materials, analytical instrumentation and equipment, ensuring fitness for use in analytical testing.
  • Oversee change control management processes, including risk assessment, documentation, and implementation.
  • Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality events.
  • Act as a Subject Matter Expert (SME) by providing technical guidance and troubleshooting support to laboratory testing teams.
  • Collaborate effectively across departments to ensure alignment and successful execution of cross-functional initiatives.
  • Identify and drive continuous improvements in analytical methods and laboratory workflows to enhance efficiency and compliance.
  • Conduct data trending and analysis of laboratory processes and analytical performance on a routine basis to identify trends and areas for improvement.
  • Collaborate as a QC representative with global teams on both global and local projects and take the initiative for improvements.
Required Skills:
  • Requires bachelor's degree in science, engineering or other related technical field. 4+ years of related experience in pharmaceutical or similar regulated industry.
  • Strong QC Microbiology experience preferred (testing, sampling, processes)
  • Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
  • Must have the ability to manage multiple tasks and responsibilities for the QC Lab.
  • Must have the ability of managing complex projects and resolving complex lab issues.
  • Must possess excellent technical and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities.
  • Should have advanced knowledge in Statistical Analysis and cGMP standards. Strong leadership, project and people management skills, and ability to make critical decisions.
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Vacancy posted 2 days ago
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