**Quality Investigations Specialist** Quality Assurance Albuquerque, NM, US Pay Rate Low: 22 | Pay Rate High: 25 + Added - 15/01/2025 Apply for Job _Our client is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum! They are looking for a Quality Investigations Specialist to join their team in Albuquerque!_ **Position Overview:** The **Quality Investigation Specialist (QIS)** will provide quality assurance oversight and serve as a subject matter expert for GMP investigations within the pharmaceutical industry. This role ensures that facilities and processes are in a constant state of readiness for regulatory inspections and supports the execution of production activities with a focus on quality, timeliness, and compliance. The QIS will contribute to continuous improvement initiatives and may supervise a team within the Quality Assurance department. **Pay rate:** $25/ hr. **Location:** Albuquerque, New Mexico **Contract length:** 3 months **Key Responsibilities:** + Lead and provide expertise for GMP investigations, ensuring adherence to industry standards + Work with Quality and Operations teams to maintain facilities and processes in a constant state of readiness for regulatory and customer inspections + Ensure timely and “right the first time” execution of production activities + Oversee commissioning and qualification activities following the validation life cycle + Conduct QA audits to identify areas for improvement in training, data collection, reporting, and manufacturing practices + Support investigations related to product complaints, deviations, and failure events + Perform root cause analysis and implement corrective actions for process-related issue + Review and approve batch records and product releases (Manufacturing and Packaging) **Qualifications:** + Bachelor’s Degree in Science, Chemistry, Biology, or related field + 1-3 years of experience in quality assurance, regulatory affairs, or related fields within the pharmaceutical industry + Knowledge of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing + Familiarity with US, European, and Japanese Compendia requirements for pharmaceutical facilities and analytical/microbiological laboratories + Proficient in calculating concentration, percentage, area, volume, and applying algebra and geometry concepts + Strong problem-solving skills and the ability to interpret written, oral, or diagram-based instructions \#INDBH \#LI-DNP We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.