Quality Specialist II - Complaints

Job description

Work Schedule First Shift (Days) Environmental Conditions Able to lift 40 lbs. without assistance, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization. How Will You Make an Impact The QA Specialist II, Product Complaints supports the investigation and resolution of product complaints in a regulated pharmaceutical CDMO environment. This role contributes to maintaining compliance with cGMP requirements while protecting product quality and patient safety. Working under general supervision, you will execute complaint investigations of low to moderate complexity, collaborate with cross-functional teams, and develop foundational expertise in complaint handling, root cause analysis, and quality systems. A Day in the Life Perform product complaint investigations of low to moderate complexity in accordance with cGMPs, internal procedures, and quality systems. Collect, document, and assess relevant data to support root cause analysis and investigation conclusions. Draft investigation reports and supporting documentation for review and approval by senior Quality staff. Escalate potential quality, regulatory, or patient safety concerns to management in a timely manner. Support implementation and tracking of corrective and preventive actions (CAPA) as assigned. Collaborate with Manufacturing, Quality Control, Supply Chain, and other functions to gather information and support investigation activities. Assist with preparation for customer inquiries, audits, and regulatory inspections related to product complaints. Follow all safety, training, and compliance requirements to maintain an inspection-ready environment. Manage assigned workload to meet established timelines while maintaining accuracy and attention to detail. Perform other duties as assigned. Education Bachelor’s degree in a health science, life science, engineering, or related discipline is required. Experience 2–4 years of experience in the pharmaceutical or biotechnology industry. Prior experience supporting or conducting GMP investigations (complaints, deviations, or quality events) is preferred. Exposure to CDMO operations or manufacturing environments is a plus. Knowledge, Skills, Abilities Working knowledge of cGMP regulations and pharmaceutical quality systems. Ability to follow procedures and apply investigation tools with guidance. Strong written and verbal communication skills, with the ability to document investigations clearly and accurately. Good organizational skills and attention to detail. Proactive and capable of managing multiple tasks and meeting deadlines in a fast-paced environment with minimal supervision.Willingness to learn, accept feedback, and grow technical and regulatory expertise. Dependable, professional, and able to work effectively as part of a cross-functional team. Physical Requirements/Work Environment Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.