• Independent and appropriate triage of potential non-conforming events to assess immediate corrections, need for subsequent deviation, and assign criticality in alignment with procedures

• Independent identification and assembly of cross-functional teams to achieve defined investigation milestones

• Identification and utilization of appropriate root cause analysis tools commensurate with the level of investigational complexity and criticality

• Independent execution and management of investigations and deliverables within the electronic Quality Management System (eQMS) in accordance with requirements defined in procedures

• Identification and timeline management of deviation corrections, corrective actions, and/or preventive actions

• Proactive communication and escalation of risks associated with investigations

• Providing investigation updates to site management and cross-functional business reviews

• Providing feedback and actively participates in deviation program metrics establishment and continuous improvement

• Potential to mentor/train investigators

• Potential to assist in developing investigation training material

• Potential to cross-train within the Quality Assurance organization to provide Quality oversight and support across other GxP tasks and programs

• Potential to support QC laboratory investigations

• Other duties, as assigned

Ideal candidates will be able to independently lead complex deviations investigations and have direct prior experience with GMP deviations in a biopharma GMP manufacturing facility.

Hard Skills

• Ability to independently lead complex deviation investigations

• Experience with GMP deviations in a biopharma GMP manufacturing facility

• Root cause analysis

• Electronic Quality Management System (eQMS) management

Soft Skills

• Proactive communication

• Cross-functional team collaboration

• Risk escalation

• Mentoring and training

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.