Manager of LIMS, Computer System Validation and Data Management

TATAA is a fast-growing company with two decades of history and is recently backed by a life sciences investment firm. The company is comprised of a team of scientists providing laboratory services, products and education / training services across a broad range of nucleic acid analysis technologies including PCR, NGS and proteomics. The company serves a variety of pharma, biotech and academic customers. This position offers an exciting opportunity to get involved early on in setting up TATAA for its next phase of growth.

ARBETSUPPGIFTER
TATAA is recruiting a candidate to act as a Manager of LIMS, Computer System Validation and Data Management in a thriving leading Contract Research Organization (CRO) specialized in molecular biology and proteomics.

Responsibilities

• Endorse the role of administrator for the Laboratory Information Management System (LIMS), starting with the active participation in the computer system validation (csv) phase.
• Pivotal role in the implementation of a 21-CFR Part 11-compliant LIMS system, requiring close interactions with IT external partners and internal scientists.
• Develop, customize and improve LIMS workflows as per internal needs and regulatory requirements.
• Sustain the LIMS in the long term, manage user requests, understands master data, maintain the validated state, process access requests, and own standard operating procedures (SOP).
• Design and deliver dedicated LIMS trainings for internal end-users.
• Support end-users in daily tasks and establishes ad-hoc, on-the-job trainings to ensure user proficiency.
• Responsible for the formatting and secure transfer of result data according to Sponsors requirements.
• Accountable for the sustainable archiving of all electronic data according to relevant quality standards.


KVALIFIKATIONER
Minimum Qualifications

• IT scientist with experience of molecular biology and/or protomics techniques; conversely, molecular biologist with high proficiency in Laboratory Information Management (LIMS) systems.
• At least 5 years hands-on experience in using, maintaining and administering Laboratory Management Information System (LIMS) in an ISO- or GxP-compliant environment, ideally a CRO.
• Familiar with the computer validation process, system execution, change control, databases, and change management.
• Familiar with one or more of the following techniques: quantitative PCR, NGS, Proteomics, automation techniques. Hands-on laboratory experience preferred in one of the above-mentioned fields.
• Problem-solving skills to understand up and downstream impacts of system changes not only for LIMS but for the company holistically as well.
• Excellent communicator and team player.
• Fluent in English.