Actalent Jobs

Description:

• Support the deviation and CAPA/SCAR Systems by investigating, reviewing, assessing, tracking, follow-up, and completing all quality events.

• Support the Change Control program by reviewing, assessing, tracking, follow-up, and completing all change control documentation.

• Maintain databases and metrics.

• Identify and communicate compliance gaps; propose phase appropriate solutions.

• Track the status of Deviations, CAPAs, and Change Controls.

• Perform internal and/or external audits, as needed.

• Support product releases by reviewing batch records.

• Support data integrity validation planning and execution.

• Support data integrity continuous improvement initiatives.

• Track data integrity activities.

• Support risk assessment activities.

• Support audits by regulatory or state agencies and partners.

• Follow applicable regulations, including FDA, ISO, ICH, and company policies and procedures.

• Support other QA department needs as identified by management.

Skills:

• QA, CAPA, change control, product release, risk assesment, deviations

Additional Skills & Qualifications:

• Bachelor’s degree or a combination of relevant education and applicable job experience

• 5+ years’ experience in an FDA regulated industry and CGMP regulations.

• Familiarity with implementing/supporting Risk Assessment program a plus.

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.