Labvantage Lims SME - Contract

Laboratory Systems Administrator / LabVantage LIMS SME Portsmouth, NH

Position: LabVantage LIMS SME,Req#: 1660Location: Portsmouth, NH (100% Onsite only)Duration: 6+ Months Contract with a high possibility of extension

Notes from the hiring manager: The manager is looking for 1-2 people who have extensive LabVantage LIMS experience to assist in Master Data alignment between a variety of platforms.

• 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.

Job Description:

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.

Education and Experience:

• Bachelor of Science: Science related discipline or relevant experience in the field
• Highly Experienced- 10+ years of experience
• LabVantage LIMS / LabVantage Platform
• LIMS / laboratory information systems experience
• Master data setup and data loading
• Data management/data cleansing
• QC laboratory operations and related data requirements
• Strong data accuracy and analytical skills
• Ability to create local work instructions

Nice to have:

• gLIMS
• MODA
• QC/regulated manufacturing environment
• Validation experience
• TrackWise / Quality Systems
• Deviations, Change Controls, CAPA
• cGMP experience

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

6+ Months SummaryResponsible 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.

• Experience in data management and familiarity with master data setup and loading processes.
• Strong attention to detail and analytical skills to ensure data accuracy and quality.
• Ability to develop clear and concise local work instructions.
• Knowledge of QC lab operations and related data requirements.
• Proficiency in using LIMS or similar data management system

• 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