Job Title: Quality Assurance Specialist Job Description Support QA activities for all pharmaceutical manufacturing processes. Support deviation/investigation activities. Address and solve CAPAs or corrective and preventive action plans. Help with drafting and writing protocols and change controls. Mentor and explain GMP to other team members. Understand a QMS system and have experience with Trackwise. Review and approve protocols, validation documents, investigations, and procedures. Responsibilities + Support QA activities for all pharmaceutical manufacturing processes. + Support deviation and investigation activities. + Address and solve corrective and preventive action plans (CAPAs). + Draft and write protocols and change controls. + Mentor and explain Good Manufacturing Practices (GMP) to other team members. + Understand and utilize Quality Management Systems (QMS) such as Trackwise. + Review and approve protocols, validation documents, investigations, and procedures. Essential Skills + Quality assurance + CAPA + Investigation + Deviation + Batch record review + Aseptic processing + Fill/finish + Trackwise + Audit + Standard Operating Procedures (SOP) + Good Manufacturing Practices (GMP) + Compliance + Veeva Vault Additional Skills & Qualifications + Bachelor's degree in a life science with 4-8 years of experience. + Experience working with batch records. + Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies. Work Environment You will be working on a team of 6 individuals. This is a 100% onsite position to support QA on the floor activities. The schedule is Monday - Friday normal business hours. The work environment is business casual, requiring good attention to detail and a high level of communication. If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com. Pay and Benefits The pay range for this position is $40.00 - $50.00 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.