Description:

Quality oversight activities for the aseptic fill/finish manufacturing suite and Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes, and support systems are compliant with company guidelines and CGMP regulations marketed products and/or their raw materials, APIs, excipients or componentsConduct investigations based on dataHelp identify root cause analysis with other teamsUpdate SOPs, protocols, validation documents, investigations, and proceduresApprove change controlsHandle QA Activities

Skills:

Quality assurance, Gmp, aseptic processing, fill finish, change control, deviation, capa, investigation, SOP, Compliance, Document control

Additional Skills & Qualifications:

BS/BA degree in a scientific discipline with 2 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent

Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing

Experience Level:

Intermediate 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.