Job Title: QA Operations InvestigatorJob Description We are seeking motivated individuals to support the Operations Compliance Team of a global bio-pharmaceutical company. As a QA Operations Investigator, you will be responsible for triaging and managing follow-up action items for level one manufacturing-related deviations. Your role will involve driving root cause analysis, writing reports, and creating robust CAPAs to improve processes. You will interact heavily with manufacturing and quality SMEs, as well as site leadership personnel. Responsibilities + Own the process of triaging and managing follow-up action items for level one manufacturing-related deviations. + Drive root cause analysis and write investigation reports. + Create robust CAPAs to improve processes. + Collaborate and communicate with SMEs, management, and site leadership. + Engage in process improvement and optimization initiatives. Essential Skills + At least 5 years of experience in writing investigations for pharmaceutical manufacturing process-related deviations. + Experience in GMP, pharmaceutical manufacturing, technical writing, root cause analysis, quality assurance, and quality control. + Knowledge in biology, chemistry, microbiology, and chemical engineering. + Familiarity with aseptic manufacturing operations. Additional Skills & Qualifications + Experience with Trackwise or Veeva Vault is a plus but not required. + Strong soft skills including clear and professional communication, initiative, workload management, and being a self-starter. + Ability to stay organized and produce results in a high-pressure environment. + Polite persistence. Work Environment This role is based in a pharmaceutical manufacturing site. Most of your time will be spent in an office setting, writing reports, and attending meetings. You will also spend time in manufacturing areas for shadowing and interviews when tracking down information from SMEs. The team is small and collaborative, working with manufacturing operations supervisors and other consultants. The company culture emphasizes an 'OWN it' mentality and patient-focused values. The dress code is business casual with close-toed flat shoes. The work schedule is generally M-F day shift with some flexibility based on business needs. Pay and Benefits The pay range for this position is $50.00 - $80.00 • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Rocky Mount,NC. Application Deadline This position will be accepting applications until Dec 27, 2024. 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.