Quality MasterControl System Administrator
UniWell Labs, Fort Worth, TX, United States
Industry Sector: Life Sciences & Technology, Dietary Supplements
Job Summary:
MasterControl Administrator to manage the configuration, installation, operation, and maintenance of various MQMS modules including Manufacturing Excellence (Mx),Manufacturing Execution System (MES), Advanced Quality Event Management (AQEM).
Key Responsibilities:
This candidate will be responsible for guiding the implementation of the MasterControl software including user access, system user rights, developing/maintaining management review reports & metrics, as well as creating and providing training to end users.
This is a user-facing role where the candidate will work with internal teams on daily usage as well as coordinating with MasterControl teams for data integrity, process controls, and configuration requirements.
The ideal candidate will have at least 3+ years of MasterControl implementation experience, a MasterControl Administrator Certification (preferred), and SDLC experience for successful MasterControl implementations including MX, QX, and AQEM.
Candidates should have a solid understanding of CGMP requirements for quality standards in an FDA regulated industry, with preference in dietary supplements or OTC pharmaceutical regulated sectors.
Perform other related duties as assigned.
Skills:
MasterControl OS, Master Manufacturing Record (MMR) and Batch Production Record (BPR) development and Implementation, Mx, Qx, AQEM, CGMP, QMS, MES, LMS, LIMS, QA.
Document Control, training learning management systems (LMS), deviation generation, CAPA management and coordination experience is a plus.
Experience with ERP software integration software such as SAGE.
Certificate of Analysis (CoA) creation using LIMS and MasterControl.
Maintain Quality and Manufacturing information dashboards using MasterControl.
Approve updated Bill of Materials (BOM) data within MasterControl.
Education:
Bachelors in Life Sciences, computer science, technical writing or related field with experience.
Location:
Onsite in-person the first 3 months for training purposes, than hybrid work is available.