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Quality Control Specialist

2 months ago

Winchester, Kentucky, United States Intellectt Inc Full time

Job Title: QA Associate I

Company: Intellectt Inc

Position Overview:

The QA Associate plays a crucial role in ensuring the quality assurance processes related to the production of solid oral dosage pharmaceuticals. This position is vital for maintaining compliance with industry standards and regulations.

Key Responsibilities:

  • Oversee and support manufacturing operations in accordance with regulatory guidelines and internal protocols.
  • Conduct thorough reviews and approvals of manufacturing documentation and real-time monitoring of production activities.
  • Perform in-process and final product testing to ensure adherence to quality standards.
  • Audit batch records for accuracy and compliance with established procedures.
  • Engage in environmental monitoring through microbial swabbing of equipment and surfaces.
  • Maintain comprehensive knowledge of all relevant SOPs, cGMP, and CFR guidelines.
  • Collaborate with cross-functional teams to assess potential deviations and facilitate investigations as necessary.
  • Document and report quality issues using the Trackwise system to ensure thorough investigations.
  • Manage the quality status of work-in-progress and finished goods in inventory systems.
  • Support continuous improvement initiatives and provide training to manufacturing personnel.

Qualifications:

  • Education: Bachelor's Degree in a relevant scientific or technical discipline is preferred, along with 2 years of related experience.
  • Alternatively, a High School Diploma with 4+ years of experience in a regulated manufacturing environment is acceptable.
  • Additional certifications such as Lean Six Sigma or ASQ are advantageous.

Skills:

  • Strong attention to detail and ability to work in a fast-paced environment.
  • Excellent communication and teamwork skills.
  • Proficient in problem-solving and analytical thinking.