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Position Title: Lab Vantage LIMS Specialist
Work Location: 101 International Drive, Portsmouth, New Hampshire 03801
Assignment Duration: 6 months
Work Schedule: Regular Office Hours
Work Arrangement: Onsite
Position Summary:
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.
Background & Context:
Reports to Portsmouth gLIMS Project Manager/Site Point of Contact (SPOC). Supervisory Organization: Quality. Key stakeholders include Quality Control, global gLIMS Team, and Manufacturing Operations. Supervision level: Direction (establishes methods and procedures for attaining specific goals and objectives; only final results typically reviewed).
Key Responsibilities:
• 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.
Qualification & Experience:
• Degree (required): Bachelor of Science – Science related discipline or relevant experience in the field.
• Language(s) Required: English preferred – Ability Level 2 - Business Fluent.
• Work Experience Area: QC, Enterprise systems, Validation – Level: Highly Experienced - 10+ years.
• 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.
Competencies & Behaviors (Core expectations):
• Agility: Learns from experience, errors and setbacks; Helps others learn from experience to develop themselves; Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond; Embraces new initiatives and drives successful implementation in his/her area; Adapts thinking and behavior to support change; Takes personal responsibility for promoting change in his/her area; Understands how to effectively engage others in the change processes.
• Business Acumen: Sets and delivers on individual and team objectives that support the company strategy; Uses knowledge of his/her business area and related areas to make correct and timely decisions.
• Collaboration: Works in partnership as an active member of his/her team and cross-functional working groups; Generously shares information and knowledge with others across teams and functions; Actively seeks out and shares different perspectives from a broad network and implements alternative approaches; Champions and role models the values of diversity and inclusion through everyday interactions in groups.
• Customer Focus: Proactively seeks to understand internal/external customer needs; Develops insights that can be used to enhance customer satisfaction or other metrics; Identifies when company and customer interests may not align and seeks effective solutions to resolve or escalate; Manages internal and external customer relations professionally and effectively; Uses systematic approaches to ensure customer key metrics are tracked and analyzed for continuous improvement.
• Driving Results: Establishes and consistently delivers on KPIs and challenging goals for him/herself (and team); Proactively shares credit for successes; Helps peers (and team) overcome performance obstacles and challenges; Secures buy-in from key stakeholders; Ensures delivery excellence for own goals and those of his/her team; Regularly solicits, assesses and addresses feedback; Appropriately prioritizes multiple demands and leads defined work to successful conclusion on time.
• Leadership: Supports others in taking responsibility for a safe and sustainable environment; Takes personal accountability for outcomes resulting from choices and behaviors of self and team; Seeks and provides feedback to their team to support professional development; Takes personal accountability for defining and implementing his/her own development and supports others to do same; Creates a positive work environment for his/her team and demonstrates high integrity; Ensures clear and direct 2-way communication within his/her team and other organization.
Working Conditions & Physical Demands:
• Work Schedule: Regular Office Hours.
• Travel: <10% = low.
• Safety: 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.
• Quality Responsibility: Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
• Environmental Demands: The normal working environment is: Office Setting.
• Physical Demands (Office and Admin related): Continuous/Frequent/Occasional as marked for Bending, Kneeling, Squatting, Climbing stairs, Climbing ladders, Walking, Sitting, Reaching, Driving, Fine motor skills, Gowning, Standing, Lifting 50 lbs (standard office profile applies; production-related section present but office setting indicated as primary).
• Mental Demands: Full comprehension of process flow and is able to identify factors which influence the process. Must be able to read and follow defined SOPs and policies. Works independently on basic manufacturing tasks, identifies, communicates and resolves non-routine events, and reviews more complex decisions with Supervisors. Must be able to use automated process equipment and tools.
Additional Information:
This job description is intended to describe the general content, identify the essential functions of the job and has been developed based upon the expected and current duties, responsibilities and requirements for the position. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Because job requirements evolve with the changing needs of the organization’s business, the organization retains the right to modify this job description at any time, whether formally or informally.
The organization is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.