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.
Lilly Microbiology Quality Assurance
