Description:

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT• Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes of facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.• Responsible for managing multiple deviation investigations simultaneously.• Provides follow up and scheduling to ensure batch release process is not impacted by outstanding deviations.• Ensure investigations will withstand regulatory scrutiny and are compliant with cGMP regulations.• Works with process experts and production personnel to fully understand and solve problems, provides technical expertise and recommends improvements.• Writes Impact Assessments and Investigation Reports, works within TrackWise.• Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems.• Performs continuous reviews and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected.• Informs Management on the progress of on-going investigations, provides information to and takes direction from the Deviation Review Board.• Utilizes Word, Excel, Documentation and other electronic systems to complete tasks.• Maintains compliance with company policies, training requirements, cGMPs and safety standards.

Skills:

technical writing, root cause analysis, capa, trackwise, gmp

Top Skills Details:

technical writing,root cause analysis,capa,trackwise,gmp

Additional Skills & Qualifications:

trackwise

Experience Level:

Expert Level

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 for other accommodation options.