Lilly Microbiology Quality Assurance Associate Post – Apply Online

Lilly Microbiology Quality Assurance Associate Post – Apply Online

Independently works within the Lilly Branchburg Process Team environment per Manufacturing Standards for Operational Excellence (MSOE), resolves key technical/quality problems and drives solutions that impact the site. Leads medium-scale projects or programs with moderate risk and/or complexity. Provides assistance to cross-functional groups and/or management with troubleshooting investigations and problem resolution.

Job Title: Quality Assurance Associate (Microbiology)

locations US, Branchburg NJ

Basic Requirements:

BA/BS degree in the sciences with a minimum of 1-3 years experience in the Biopharmaceutical industry. Previous technical experience should be in laboratories (microbiology preferred).

Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.

Additional Preferences:

Must have experience in developing, reviewing and/or approving the following types of development/validation documents: Validation Plans, User/Functional Requirement Specifications, IQ/OQ/PQ Protocol and Reports, Requirements Traceability Matrix, and Validation Summary Reports.

  • Must possess a conceptual understanding of all Quality functions and business areas.
  • Must possess depth and/or breadth of expertise within area of responsibility.
  • Must have the ability to function in a fast-paced environment and communicate effectively with management.
  • Must be able to work in a cross-functional environment.
  • Must have demonstrated ability to work independently.
  • Must be proficient in Microsoft applications.

Responsibilities:

  • Evaluate deviations and ensure appropriate root cause/likely assignable cause(s) and assess quality impact. Recommend CAPAs and ensure CAPAs implemented are effective.
  • Review and approve respective development and validation documentation.
  • Evaluate change controls and associated risk assessments.
  • Perform training within group or throughout organization as needed.
  • Write/escalate Notifications to Management, as applicable.
  • Ensure timely completion of all quality plan objectives and milestones. Support the on-time performance metrics.
  • Assist in creating quality metrics. Keep Quality management informed of compliance issues.
  • Perform periodic walk-throughs of Laboratories.
  • Assist in activities associated with technology transfers to and from Lilly Branchburg facilities, as applicable.
  • Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Laboratories. Support lot release through ensuring timeliness resolve of compliance issues, as applicable.
  • Ensure compliance with applicable regulatory guidelines and GxP computer systems to global electronic records/signatures regulations (21 CFR Part 11, Annex 11, etc. as applicable); Perform review of regulatory submissions as necessary.
  • Perform the compliance and risk evaluation of respective systems and departments.
  • Participate in internal audits performed by partners, Lilly corporate, and/or regulatory agencies, as applicable.
  • Identify and lead a process improvement projects that impact systems used in a specific functional area.
  • Serve as core member on Process Team(s), a cross functional group charged with making medicine, continuous improvement, and site support in accordance with Manufacturing Standards of Operational Excellence.
  • Serve as key Quality liaison between disposition and compliance by supporting lot release through ensuring timeliness resolve of compliance issues, as applicable.
  • Perform Analysis Audit Trail Reviews.
SEE ALSO
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Lilly Microbiology Quality Assurance

Apply Online

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