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Quality Deviation Investigator II in Albuquerque, NM

Summary:

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

The Quality Deviation Investigator (QDI) II is responsible for leading investigations to ensure the written report contains technical merit and completeness according to regulatory expectations. This position will cross-functionally collect necessary data and information associated with manufacturing and laboratory deviations. This position will lead root cause analysis sessions with site SMEs and determine the associated corrective action to prevent the variation from recurring. This person will be a crucial player in the Quality Assurance Investigations team and a champion for quality priority principles and compliance within the Operations organization. This position reports directly to the Quality Investigations Manager. Additionally, the QDI II provides mentorship and guidance to QDI I’s.

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:

• Develops a comprehensive understanding of the manufacturing processes and the associated risk management control strategy to identify process risks and critical controls around the related processing steps

• Provides consistent direction and timely completion of deviation investigations to ensure ongoing consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with Manufacturing and Quality teams

• Collaborates with other leaders across the organization and assists in the continuous improvement and life cycle management of implemented GMP policies and quality management systems

• The investigation owner will lead the investigation of deviations that occur in operations. Author and manage the inquiries to meet key timing commitments with well-investigated and well-documented deviation reports

• Work with quality assurance, quality control, operations, engineering, maintenance, calibration, safety, and supplier quality management to ensure the appropriate and timely determination of scope, product impact, root cause, and corrective actions

• Determines scope, product impact, root cause, and corrective actions for procedure deviations. Proposes and implements effective CAPA to eliminate these causes

• Determines appropriate preventative actions to prevent the reoccurrence of the deviation and author’s deviations and conducts personnel interviews to determine the root cause of the variation

• Update SOPs or other official documents as required

• Foster a culture of continuous improvement through employee selection, training, and mentoring while focusing on operational efficiency and eliminating “non-value-added” activities

• Provide a positive and equitable working environment emphasizing Curia Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance

• Complete any other duties/responsibilities assigned by senior management

• Read/interpret SOPs to ensure compliance

• Maintain up to date trainings

• Other duties as assigned

Education and Experience:

• Bachelor’s Degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or related field of study

• Minimum of three (3) to five (5) years’ related quality deviation experience

• Experience with deviation or investigation management systems

• Experience in a cGMP-regulated manufacturing Pharmaceutical, Biotechnology and/or QA/QC

• Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment

• Technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech environment, or related industry, preferred

• Proficient in Deviation Management (i.e., TrackWise), preferred

Supervisory Responsibilities:

This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

Language Skills:

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical Skills:

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other Skills and Abilities:

• Provides guidance and mentorship to team members

• Fosters a collaborative and positive work environment

• Champions change

• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.

• Demonstrates strong attention to detail

• Comprehend and follow SOPs, cGMPs, and detailed instructions to successfully produce sterile quality products

• Document information, events, and cGMP manufacturing processes, accurately and completely

• Perform duties in an organized, detail-oriented manner. Work and communicate well with others in a team environment

• Ability to author and review standard operating procedures, on-the-job-trainings, and other controlled documents

• Ability to put complex thoughts and issues into writing so that an educated but uninformed reader can understand and make decisions based on the written investigation report

• Proficient in using the following methodology: 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, and Human Error Reduction

Other Qualifications:

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

Must be able to obtain and maintain gowning certification

Must be able to obtain and maintain media qualification

Must be able to wear a respirator

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

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.

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