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Position Title: Master Data Specialist
Work Location: 101 International Drive Portsmouth New Hampshire 03801
Assignment Duration: 7 months
Work Schedule: Regular Office Hours
Work Arrangement: Onsite
Position Summary: Responsible for the preparation, cleansing, validation, loading, and ongoing support of QC master data for gLIMS implementation. Partners with QC SMEs and project teams to ensure accurate, complete, and compliant data migration, support go-live readiness, and maintain data integrity throughout the project lifecycle.
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 LIMS or similar systems and familiarity with quality standards and regulatory requirements.
Qualification & Experience:
• Degree (required): Bachelor of Science in 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: Entry Level - 0-4 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.
Working Conditions & Physical Demands (If Applicable):
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.
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 listed for bending, kneeling, squatting, climbing stairs, climbing ladders, walking, sitting, reaching, driving, fine motor skills, gowning, standing, lifting 50 lbs (per JD table).
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 (If Applicable): 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 our organization’s business, our organization retains the right to modify this job description at any time, whether formally or informally. Our 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.