We are located in North Augusta, SC. Relocation is REQUIRED. Relocation assistance available. Apply now to learn more!
Primary Responsibilities:
- Advanced understanding and technical knowledge of instrumentation, lab functions, and techniques to identify and troubleshoot problems are required to complete work assignments.
- Provides advanced troubleshooting to metrologists working on critical equipment in the lab and specifics regarding projects.
- Liaison between departments and other metrologist.
- Conducts calibration, qualification, and support of laboratory instrumentation such as UPLCs, HPLCs, GCs, UV spectrophotometers, MALS detectors, IC, MS, KF, lyophilizers and other related analytical and process equipment.
- Responsible for handling new instrument onboarding including tracking/scheduling of all IQ/OQ/PQ tasks and ensuring calibration is performed prior to release.
- Responsible for assisting metrology supervisor in maintaining the calibration schedule in Master Control.
- Prepare detailed and accurate documentation of testing performed and works within the in-house SOPs and industry standards for compliance (Including all FDA regulations, international ICH standards, and USP guidelines).
- Performs troubleshooting and instrument maintenance on out of service equipment as requested in work orders submitted from respective departments.
- Assists metrology supervisor in completing CAPA, deviation, and change control action items to assist metrology management.
- Train and mentor new metrologists on calibration and preventative maintenance protocols.
- Responsible for leading various projects in conjunction with the direction of the Department Manager.
- Helps metrology supervisor conduct trainings with other groups on site.
- Assists metrology supervisor in maintaining the preventative maintenance schedule in according with the site SOP.
- Assists in performing preventative maintenance on equipment to uphold the schedule set forth by company SOPs. Preventative maintenance will be performed as instructed in preventative maintenance instructions (PMIs).
- Can learn and utilize AmbioPharm’s document management system as it applies to relevant trainings, logging and submitting calibration documentation, completing work orders, and logging and completing preventative maintenance instructions.
- Perform daily and weekly instrument checks as defined by departmental checklists.
- Pays specific attention to equipment operating practices and conditions to minimize equipment down time, lower maintenance costs, reduce time to run project and repeat of work.
- Develop teamwork and communication skills through active listening and honest dialog with peers and supervisors.
- Communicate effectively with internal team personnel, as well as external team.
Qualifications:
- Minimum Education: Bachelor’s degree in Life Science, Engineering or Electronics.
- 5 or more years’ experience working with HPLC’s is required (Waters or Agilent).
- Previous experience working with technical projects.
- Must have moderate knowledge of Empower software.
- Must show competence in a range of troubleshooting areas as assessed through interview.
- Proficiency in use of software including Microsoft Word and Microsoft Excel.
- Good communication and writing