Job Title: Senior Quality Assurance SpecialistJob DescriptionSupport QA activities for all pharmaceutical manufacturing processes. Engage in deviation and investigation activities, addressing and solving CAPAs or corrective and preventive action plans. Assist in drafting and writing protocols and change controls. Mentor and explain GMP to other team members. Understand and have experience with QMS systems, such as TrackWise. Review and approve protocols, validation documents, investigations, and procedures.Responsibilities
Support QA activities for all pharmaceutical manufacturing processes
Engage in deviation and investigation activities
Address and solve CAPAs or corrective and preventive action plans
Assist in drafting and writing protocols and change controls
Mentor and explain GMP to other team members
Understand and have experience with QMS systems, such as TrackWise
Review and approve protocols, validation documents, investigations, and procedures
Additional Skills & Qualifications
BS in a life science with 5-10 years of experience
Experience working with batch records
Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies
Work EnvironmentYou will work on a team of 6 individuals. This position is 100% onsite to support QA floor activities. The schedule is M-F 9:00am-5:00pm with some flexibility to a 10:00am-6:00pm schedule. The work environment is business casual, requiring good attention to detail and a high level of communication.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.
