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Job Title: Senior Quality Control Specialist, LIMSJob Description

The Senior Quality Control Specialist, LIMS role is responsible for the deployment and administration of the QC Laboratory Information Management System (LIMS). This role represents QC in the development, configuration, validation, implementation, and maintenance of the LIMS. It encompasses QC functionality including analytical and microbiology testing, environmental monitoring, raw materials, critical reagents, stability, and sample management to support compliance with regulatory requirements and commitments for clinical and commercial products.

Responsibilities

• Understand and execute change management in a GMP environment and drive changes through appropriate quality systems.

• Support deviations and LIRs with LIMS information, as needed.

• Collaborate with stakeholders to develop requirements and a long-term vision for LIMS.

• Drive the development and implementation of the LIMS by partnering with IT and external vendors.

• Develop and regularly update key project information such as status, timelines, scope statements, budgets, resources, risks, issues, decisions, and action items.

• Manage enhancements, incident investigations, and changes for a multi-site, global LIMS.

• Draft program-related support documents including operational SOPs, Work Instructions, System Impact assessments, and change controls, as needed.

• Track and resolve LIMS support program issues and identify potential enhancements to the system.

• Independently plan, manage, and execute assignments, contribute to project planning, and support product stability programs including the generation of stability protocols in LIMS.

• Ensure compliance with site systems and regulatory requirements working within a cGMP environment.

• Manage events, deviations, or QIPs related to any LIMS activities ensuring they are closed by the set due date.

• Manage changes and updates through a Quality System (via change control or CAPA).

Essential Skills

• Good understanding of, and experience with, LIMS within a cGMP-regulated environment.

• Experience building, configuring, and qualifying the LIMS system.

• Strong attention to detail and good communication skills.

• Organizational and planning skills with the ability to explain and train succinctly.

• Ability to manage external partners with respect to technical support activities.

Additional Skills & Qualifications

• Bachelor’s degree in a relevant discipline (biological sciences, computer science, or equivalent).

• Minimum of 5-10 years of experience in a cGMP laboratory including at least 3 years as a LIMS administrator.

• Experience with translating business documents (batch records, test methods, stability protocols) into technical requirements and configuring in a LIMS solution.

Work Environment

This role is based in an office environment and requires compliance with site systems and regulatory requirements. The individual must be technically minded and possess personal qualities such as attention to detail and good communication skills.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.