Quality Assurance Specialist

1 week ago

Concord NC, United States BioSpace Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at BioSpace. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our automated warehouse operations. This includes providing daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures/master formula revisions, validations, batch disposition, commissioning, and qualification activities.

Key Responsibilities
  • Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
  • Lead, mentor, and coach operations and support personnel on quality matters.
  • Ensure regular presence in warehousing areas, while also supporting device assembly and packaging areas, to monitor GMP programs, and quality systems.
  • Active on local process teams with focus on Warehousing operations or indirect participation through project support activities.
  • Ability to assess and triage deviations/observations that occur within the warehouse area.
  • Work with Lilly support groups and external partners to resolve or provide advice on receiving or shipping issues.
  • Approve commissioning qualification/validation documents for computer systems and equipment related to the warehousing operations, to ensure compliance with quality standards.
  • Participate in self-led inspections and provide support during internal/external regulatory inspections.
  • Effectively review and/or redline to ensure quality attributes are met. (i.e., deviations/observations, procedures, technical studies, validation protocols, change controls, and engineering documents).
  • Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization.
  • Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function, with focus on the warehousing processes (e.g., receiving, shipping, incoming material inspection).

Requirements
  • Experience in GMP facility.
  • Computer Systems Quality (CSQA) experience.

Education Requirements
  • Bachelor's degree, (preference in science, engineering, computer, or pharmaceutical related field of study).

Preferred Attributes
  • Demonstrate strong oral and written communication and interpersonal skills.
  • Demonstrated decision making and problem-solving skills.
  • Demonstrate knowledge and understanding of manufacturing process and Quality Systems.
  • Proficiency with computer systems including Microsoft office products, inventory management systems, and deviation management systems (i.e., SAP, Trackwise, etc.).
  • Strong attention to detail.
  • Proven ability to work independently or as part of a team to resolve issues.
  • Previous experience in warehousing operations.
  • Previous experience with ASRS warehousing, Autonomous Guided Vehicles, and integrated systems.
  • Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
  • CQE, or CQA certification from the American Society for Quality (ASQ).
  • Previous facility or area start up experience.

Additional Information
  • May be required to respond to operational issues outside of core business hours/days.
  • Applicant may work in various areas within the facility. Mobility requirements should be considered when applying for this position.
  • Ability to work 12 Hour Rotating Shifts (Not Eligible for Remote Work).
  • Ability to work overtime as required.
  • Ability to travel up to 10% for meetings and training required.

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