Job Title: Sr. Quality Control Specialist

Job Description

The Sr. 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 as it relates to QC functionality, including analytical and microbiology testing, environmental monitoring, raw materials, critical reagents, stability, and sample management. This position supports 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 the appropriate quality system.

• Own changes, as required.

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

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

• Drive 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 investigation, 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 product stability programs, including generating stability protocols in LIMS and supporting as needed accessing final reporting or trending of stability data.

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

Essential Skills

• Experience with LIMS within a cGMP-regulated environment.

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

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

• Technically minded with attention to detail and good communication skills.

• Organization and planning skills with the ability to explain and train in a succinct manner.

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

• Experience with configuring and implementing a LIMS.

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

• 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).

Work Environment

This role primarily involves working in an office environment.

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.