Job Description

Senior Specialist LIMS in Rensselaer, NY

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential job duties

• Lead and oversee LabVantage LIMS within the quality control laboratory; support enhancements and integrations.
• Validation & Compliance:Execute validation activities, ensuring compliance with GxP, data integrity, and CSV requirements.
• Documentation & SOPs: Maintain and update technical documentation, SOPs, and training materials.
• User Training: Provide support and training on LIMS including new system functionalities.
• Data Governance & Quality: Enforce data integrity standards, version control, and data accuracy across all laboratory processes. Ensure compliance with global corporate policies and regulatory standards (e.g., FDA 21 CFR Part 11, cGMP, ISO 17025).
• Cross-Functional Collaboration: Partner with lab subject matter experts (SMEs) to gather business requirements and map existing workflows to system capabilities.
• Documentation: Own and update LIMS Standard Operating Procedures (SOPs)
• Build and maintain test definitions, sampling plans, specifications, and stability protocols in LIMS, in collaboration with QC SMEs.
• Support troubleshooting of data-related issues.
• Work with IT System Administrator to develop user requirements and test scripts for custom scripts, code, or automation tools to support LIMS integration with analytical instruments and other enterprise systems.
• Lead QA and QC to test system settings, user roles, and permissions.
• Support internal and external regulatory audits and inspections.
• Lead QC ongoing LIMS improvements and upgrades.

Education, experience, certification and licensures Required

• Bachelor's degree in Chemistry, Biology, Life Sciences or related field
• Minimum of 8 years of experience with pharma laboratory applications (LIMS, LES, ELN).
• Strong experience with LabVantage LIMS master data building
• Understanding of GxP, data integrity, and computer system validation requirements.
• Understanding of analytical testing and techniques
• Experience writing and updating technical documentation, SOPs, and training materials.

Preferred

• Experience with LIMS as an end user and/or participation in an LIMS implementation.
• Software development experience with Java and/or Groovy.

Knowledge, skills and abilities

• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.
• Ability to work in a fast-paced, regulated environment.
• Proactive mindset with the ability to anticipate and troubleshoot issues.
• Exceptional analytical thinking, strong attention to detail, and excellent verbal/written communication skills to bridge technical and scientific teams.

Supervisory responsibilities

This position does not have supervisory responsibilities.

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Pay Range: $117,000-$145,000

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.

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