Lab Specialist

Job Summary

The Laboratory Specialist is responsible for executing and supporting laboratory projects and routine operations in a regulated cGMP environment. This role supports activities such as equipment qualification, method transfer, method validation, laboratory investigations, documentation updates, and continuous improvement initiatives. The position collaborates cross-functionally with Quality, Operations, Engineering, and global laboratory teams to ensure compliant, eficient, and reliable laboratory performance.

Essential Duties and Responsibilities

• Plan and execute local laboratory projects including quality and safety initiatives.
• Participate in local and global laboratory projects and represent the Kinston Laboratory.
• Coordinate and execute internal equipment qualifications, methods transfers and methods validations.
• Prepare capital expenditure reports for the acquisition of new lab equipment.
• Drive assigned projects from protocol development through execution, data analysis, and final report completion.
• Perform laboratory investigations for deviations, out-of-specification (OOS), and nonconformance events.
• Support routine laboratory testing and review laboratory documentation for accuracy, completeness, and compliance.
• Support in training laboratory personnel on methods, procedures, equipment, and good documentation practices.
• Prepare, review, and revise laboratory procedures, test methods, protocols, and work instructions to maintain cGMP compliance.
• Maintain current knowledge of applicable cGMP requirements, data integrity expectations, and internal quality procedures.
• Collaborate effectively across functions while working independently with a high level of initiative, adaptability, accountability, and a positive attitude.
• Support implementation and evaluation of new laboratory technologies, methods, and process improvements.
• Perform other duties as assigned.

Education

• Masters degree in Science related discipline preferred.
• 3-5 years of professional experience in a lab environment or similar role .
• Experience with Electronic Document Management Systems.
• Experience with validations and project management.

Work Experience

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• Minimum 3 years 3 -5 years of professional experience in a lab environment required and
• Experience in pharmaceutical/medical device field and implementing laboratory training programs required and

Preferred Knowledge, Skills and Abilities

• Proficiency in English
• Background in cGMP related industry
• Background in Project Management.
• Strong competence in computer systems. 
• Good verbal and written communications skills.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Challenge processes remain open to ideas and changes, to continuously improve and seek better alternatives and drive change.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.
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Additional Requirements

• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Use written and oral communication skills
• Read and interpret data, information and documents
• Analyze and solve problems
• Observe and interpret situations
• Learn and apply new information or new skills
• Must be able to travel up to 5% of the time