Job Title: Quality Assurance SpecialistJob Description Support QA activities for all pharmaceutical manufacturing processes, manage deviations and investigations, address and resolve CAPAs, draft and write protocols and change controls, mentor team members on GMP, and understand and utilize QMS systems like Trackwise. Responsibilities + Support QA activities for all pharmaceutical manufacturing processes + Manage deviation and investigation activities + Address and resolve CAPAs (Corrective and Preventive Action Plans) + Draft and write protocols and change controls + Mentor and explain GMP (Good Manufacturing Practices) to other team members + Review and approve protocols, validation documents, investigations, and procedures Essential Skills + Quality Assurance + CAPA management + Investigation and deviation handling + Batch record review + Aseptic manufacturing and fill/finish processes + Trackwise or similar QMS systems + Audit and SOP compliance + GMP knowledge Additional Skills & Qualifications + BS in a life science field + 4-8 years of experience in quality assurance + Experience working with batch records + Familiarity with validation of aseptic manufacturing technologies Work Environment You will be working on a team of 6 individuals. This position is 100% onsite to support QA on the floor activities. The schedule is night shift: Monday-Wednesday from 6pm-6am, and Thursday from 6pm-10pm. The environment is business casual, and candidates must have good attention to detail and a high level of communication. Pay and Benefits The pay range for this position is $40.00 - $50.00 • 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 North Billerica,MA. Application Deadline This position will be accepting applications until Dec 20, 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.