Lab Operations Specialist

Job Title:

Lab Operations Specialist

Job Description

The Lab Operations Specialist supports end-to-end sample management and laboratory operations across multiple departments in a regulated environment. This role follows standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) to ensure accurate documentation, efficient material movement, and compliance with quality standards. The position offers exposure to cleanroom activities, ERP and quality systems, and provides a strong foundation for career growth in GMP operations.

Responsibilities

+ Support sample management activities across several departments by following established SOPs and GMP procedures.

+ Move materials and samples efficiently between all relevant departments to support ongoing laboratory operations.

+ Ensure all samples are accurately documented and tracked in the ERP system and associated quality systems using Excel.

+ Perform biopsy accessioning activities for all applicable processes, ensuring correct identification, labeling, and documentation of samples.

+ Support receiving and accessioning of incoming samples and materials, ensuring they meet defined acceptance criteria.

+ Assist with media preparation, inventory management, and general laboratory support tasks as needed.

+ Help team members gown up and follow proper cleanroom entry and exit procedures in compliance with GMP requirements.

+ Perform accurate and timely data entry in Excel and other systems to maintain complete and compliant records.

+ Follow cGMP, SOP, and quality guidelines in all daily operations to maintain a controlled and compliant environment.

+ Collaborate with cross-functional teams to ensure smooth workflow, timely sample processing, and adherence to production schedules.

+ Identify and report any deviations, discrepancies, or issues in sample management or documentation to appropriate personnel.

+ Contribute to continuous improvement by following best practices and supporting updates to procedures and workflows as needed.

Essential Skills

+ 2-4 years of experience in a laboratory, sample management, or related operational role.

+ Associate degree (or equivalent) in a relevant scientific, technical, or related field.

+ Hands-on experience with sample management, including receiving, accessioning, tracking, and documentation.

+ Proficiency with Excel, including accurate data entry and management of spreadsheets for tracking samples and inventory.

+ Experience working with ERP systems and quality systems for sample and materials documentation.

+ Working knowledge of GMP and cGMP principles and the ability to follow SOPs in a regulated environment.

+

Experience with laboratory operations, including media preparation and inventory management.

+ Strong attention to detail and accuracy in data entry and documentation.

+ Ability to follow structured procedures and maintain compliance with quality and regulatory requirements.

+ Effective communication skills and the ability to work collaboratively across multiple departments.

Additional

Skills & Qualifications

+ Experience supporting biopsy accessioning or similar clinical or manufacturing sample workflows.

+ Familiarity with cleanroom operations, including gowning procedures and behavior in controlled environments.

+ Exposure to ERP and quality systems beyond basic usage, such as troubleshooting or process improvements.

+ Demonstrated ability to manage multiple tasks and priorities in a fast-paced operational setting.

+ Interest in developing a long-term career in GMP operations and laboratory support functions.

+ Motivation to learn new systems, processes, and regulatory requirements to support continuous professional growth.

Work Environment

The role is based in a laboratory and regulated production environment that operates under SOPs, GMP, and cGMP standards. The standard schedule runs Sunday through Thursday from 8:00 a.m. to 4:30 p.m. The position involves frequent interaction with multiple departments, movement of materials and samples throughout the facility, and regular use of ERP systems, quality systems, and Excel for documentation and tracking.

The work includes time in cleanroom areas where proper…