Specialist II, QC Systems

$65,000 - $87,500/Yr

Resilience Government Services, Inc. - East Norriton, PA

Full-time - Mid Level

East Norriton, PA

About the position

The Specialist II, QC Systems at Resilience is responsible for supporting the LIMS system at the East Norriton facility. This role involves daily maintenance, configuration updates, and process enhancements of the LIMS system, ensuring that all related business needs are met in collaboration with various operational teams. The position also requires validation and change activities to maintain compliance with standard operating procedures.

Responsibilities

• Development and configuration of test method attributes within LIMS.
• Translation of test methods into the Laboratory Execution System module of LIMS.
• Collaboration with Analytical Development and Quality Control colleagues to ensure proper method configuration within LIMS.
• Generation and execution of validation (user acceptance testing) of LIMS test methods.
• Configuration, revision and validation testing of LIMS sample plans.
• Configuration of stability studies in LIMS.
• Establishment and/or revision of LIMS related processes.
• Daily support and training for LIMS end-users.
• Other activities as assigned.

Requirements

• Experience with operating in a LIMS environment and system configurations.
• Basic understanding of computer system validation.
• Basic understanding of cGMP requirements.
• Relevant experience within a GMP environment.

Nice-to-haves

• Demonstrated knowledge / thorough understanding of LES/ELN modules of a LIMS environment, preferably LabVantage LIMS.
• Experience in building test methods and/or processes within LIMS.
• Strong planning and organizational skills.
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders.
• Excellent attention to detail.

Benefits

• Equity participation
• Annual cash bonus program
• 401(k) plan with a generous company match
• Comprehensive healthcare (medical, dental, and vision)
• Family building benefits
• Life and disability insurance
• Flexible time off
• Paid holidays
• Other paid leaves of absence
• Tuition reimbursement
• Support for caregiving needs