Responsible for the accurate setup and loading of master data into the gLIMS according to global guidelines and data principles.
This role plays a crucial part in ensuring data integrity and establishing local support structures for ongoing data management
Key Accountabilities:
Perform local master data setup and load in alignment with global guidelines and data principles.
Build and input all initially required master data into the global LIMS system, including consumables, sampling plans, specifications, parameter lists, test methods, and LES templates.
Conduct local data cleansing to ensure data quality and accuracy.
Develop local work instructions to detail the execution of global processes at site level.
Proficiency in using Lab Vantage LIMS or similar systems and familiarity with quality standards and regulatory requirements.
Ability to work independently and with the team with little guidance.
Responsibilities
Adherence to cGMP is required at all times during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions.
Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety, the safety of their team and the safety of others.
Skills:
Advanced technical knowledge of Quality control and manufacturing operations.
Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
Demonstrated ability to manage medium to large sized projects within required timeframes.
Demonstrate ability for effective Planning, Organizing and Controlling competency
Demonstrate sound decision making.
Ability to work inter-departmentally and with customers.
Demonstrates role model behaviors for GMP and Safety behaviors
Strong written and verbal communication skills
Ability to work in MS Project, Word, Excel, PowerPoint
Education:
Bachelor of Science, Science related discipline or relevant experience in the field
Numbers & Facts
Location
Portsmouth, NH
Skills
Application Programming Interface (API)unmatched
Change Controlunmatched
Cleaning Equipmentunmatched
Communication Skillsunmatched
Computer Systemsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Data Managementunmatched
Data Qualityunmatched
GMP (Good Manufacturing Practices)unmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Systemsunmatched
Manufacturing Operationsunmatched
Microsoft Excelunmatched
Microsoft PowerPointunmatched
Microsoft Projectunmatched
Microsoft Wordunmatched
Presentation/Verbal Skillsunmatched
Quality Assurance Methodologyunmatched
Quality Controlunmatched
Quality Metricsunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Safety Complianceunmatched
Safety Processunmatched
Safety Trainingunmatched
Safety/Work Safetyunmatched
System Validationunmatched
Systems Administration/Managementunmatched
Time Managementunmatched
Writing Skillsunmatched
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