Quality Investigations Specialist in Albuquerque, NM

　　Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

　　The Job title is an integral part of the Curia team, contributing to our success by planning and conducting activities concerned with the quality assurance of industrial processes, materials, and products by performing the following duties.

　　Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

　　Essential Duties and Responsibilities:

　　Provides QA oversight/leads and subject matter expertise for GMP investigations.

　　Works with Quality and Operation to assure facilities and processes are in a constant state of readiness for regulatory and customer inspections.

　　Works with Quality and Operations to assure on-time and “right the first time” execution of production activities.

　　Provides oversight and subject matter expertise for commissioning and qualification activities as defined per the validation life cycle.

　　Performs audits of QA to identify areas for improvement in training, data collection and entry, report systems, and manufacturing.

　　Reviews GMP documents for company and contractor/customers.

　　Supports product complaints, deviations, and failure investigations.

　　Serves as analytical and technical QA resident expert.

　　Contributes to CURIA’s core values of Quality, Timeliness, Communication, and Profitability.

　　Batch Record review and release of the product (Manufacturing and Packaging).

　　Investigation or Closure of major investigations. Investigation and/or Closure of Customer Complaints.

　　Performs root cause analysis and implementation of corrective action for process-related concerns.

　　Recommends and enacts changes to applicable SOPs.

　　Supports CURIA Compliance department during FDA and other agency inspections as well as customer and internal audits.

　　Maintains a working knowledge of government and industry quality assurance codes and standards.

　　Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.

　　Interface with Engineering and Operations to ensure transfer to Production of new products are following approved data.

　　Participates in the site or global projects and improvement efforts, as needed.

　　Establishing and maintaining effective working relationships with Clinical Supply Chain Management, Production and Warehouse/Distribution staff, corporate and site Quality, study management, and regulatory affairs.

　　Other duties may be assigned.

　　Supervisory Responsibilities:

　　None.

　　Education and/or Experience

　　Bachelor’s Degree in Science, Chemistry, or Biology with less than three (3) years of experience in quality assurance and/or regulatory experience in the Pharmaceutical industry with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing. Must know the US, European and Japanese Compendia requirements for a pharmaceutical facility and an analytical/microbiological laboratory.

　　Language/Communication Skills

　　Ability to read, analyze and interpret professional journals, technical procedures, and governmental regulations. Strong written and verbal communication and presentation skills including the ability to independently write develop and write procedures.

　　Mathematical Skills

　　Ability to calculate formulas and amounts such as concentration, percentage, area, volume, and proportion. Ability to apply the mathematical concepts from algebra and geometry.

　　Reasoning Ability

　　Ability to solve problems with a variety of variables using experience. Ability to interpret instructions furnished in written, oral, diagram, or schedule form.

　　Other Qualifications:

　　Must pass a background check

　　Must pass a drug screen

　　Physical Demands

　　While performing the duties of this job, the employee is regularly required to sit; use hands to manipulate, handle, and feel; and be able to talk and hear. The employee frequently is required to reach with hands and arms. The employee is required to stand; walk, and occasionally required to climb or balance; stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and the ability to adjust focus.

　　Work Environment

　　While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet.

　　Note

　　This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.

　　All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.