Job Description
Target PR Range: 30-40/hr
*Depending on experience
Hybrid - 4 days per week onsite
Ideal Candidate: Strong Empower knowledge required. B.S. and 5+ YOE. Understanding of UPLC & HPLC's.
be responsible for supporting the QC Chemistry team as the Business Process Owner (BPO) of the Empower computerized system and as a business subject matter expert for Chemistry methods. Responsibilities will include ownership of the Empower system including accountable for authorizing new accounts and account changes. They also conduct periodic non-privileged user access reviews. The Empower BPO is the site single point of contact responsible for the end-to-end process, including governance. They make decisions about how changes will impact the Empower system, manage related change controls, oversee system performance, own site related documents, metrics, exceptions, deviations, and continuous improvement. Writing procedures and reports, executing activities to support initial lab equipment installation, qualification, and validation. Method transfers and training development as well as support of implementation of computerized systems. The QC Chemistry BPO will initially report directly to the Director of Quality Control. This individual will be a subject matter expert on QC Chemistry Laboratory operations and testing. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.
Day to Day:
Leading the QC Chemistry activities including system qualification and validation of Empower 3 FR5 and other upgrades.
Conduct training, troubleshooting, managing different aspects of Empower BPO role and attendance at meetings.
Assisting with review of validation documents to support UPLC, HPLC equipment and CE computerized systems.
Develop the Empower based method transfer plan.
Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, and technical assessments.
Execute applicable BPO responsibilities: review/approval of Empower Template Qualification documents, unlocking channels and processing methods, increasing table space, locking/unlocking projects, maintaining user types/groups, maintaining project access
Assisting with procurement activities for consumables and critical reagents for lab start up.
Own and manage Deviation, CAPA and Change Control records to support Quality Control.
Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
Job Tags
Contract work, Shift work,