LIMS Specialist II (Experienced) job vacancy

Vacancy expired!

Note : This is a hybrid role and candidate needs to be onsite twice a week.

Qualifications:

Minimum Education Requirements:

B.S. Degree in Biology, Chemistry (or related sciences), or Information Technology with at least 5+ years of industry experience, an M.S. with 3-4 years of related experience, or a Ph.D. with 1 year of related experience.
Required Experiences / Skills:
Direct experience participating in computer system validations
Extensive experience utilizing or implementing custom or commercial Laboratory Information Management Systems (LIMS) in a regulated bioanalytical laboratory.
Experience driving improvements for regulated bioanalytical data workflows either directly within a LIMs system or through other applications (e.g. Microsoft Excel)
Capable of working independently under project timelines
Strong collaborator, possessing both excellent verbal and written communication skills

Highly Preferred Experience / Skills:

Experience working with vaccine bioanalytical assays, primarily those involved with immunogenicity or molecular-based assessments
Working knowledge of data delivery standards (e.g. CDISC) and applicability to bioanalytical data
Strong MS Excel knowledge as well as general SQL query development skills and ability to understand database relationships and structures
Ability to develop process flow diagrams within existing tools (e.g. MS Visio)

Responsibilities:

Participate in the development, validation, acceptance testing, and implementation of LIMS systems or related enhancements, in partnership with Client IT and system vendors to meet the needs of various bioanalytical singleplex and multiplex assays.
Develop a working knowledge of existing LIMS functionality as well as the data analysis requirements & acceptance criteria for various bioanalytical methods to setup assay data flows and LIMS analysis modules.
Manage day to day LIMS activities for method qualification/validation and clinical study support including user training, troubleshooting, study setup, and management of clinical sample reconciliation and data transfers in line with regulatory data standards.
Execute computer system validations, including the development of system requirements and acceptance test scripts, followed by formal system testing. Validation work may be conducted for either LIMS or associated laboratory computerized system.
Operate within a regulated bioanalytical laboratory, participating as needed in regulatory audits as a LIMS subject matter expert.
Develop departmental SOPs and related computer work instructions associated with LIMS or related systems.

Note : This is a hybrid role and candidate needs to be onsite twice a week.

Contact:

Bhuvana Krishna

)