Quality Investigations Specialist in Albuquerque, NM.

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

The Quality Investigations Specialist is an integral part of the Curia team, contributing to our success by providing Quality Assurance oversight and subject matter expertise for current Good Manufacturing Process (cGMP) investigations.

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.

We proudly offer:

Generous benefit options (eligible first day of employment)

Paid training, vacation and holidays (vacation accrual begins on first day of employment)

Career advancement opportunities

Education reimbursement

401k program

Learning platform

And more!

Supervisory Responsibilities:

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

Responsibilities:

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

Works with Quality and Operations 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

Supports product complaints, deviations, and failure investigations.

Subject matter expert for all related analytical and technical Quality Assurance

Contributes to CURIAs core values of Curiosity, Urgency, Respect, Integrity and Accountability

Reviews and closes investigations and customer concerns

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

Recommends and initiates 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

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

Read/interpret SOPs to ensure compliance

Maintain up to date trainings

Other duties as assigned

Required qualifications:

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

Education and Experience:

Bachelors Degree in Science, Chemistry, Biology or related field of study, preferred

Associates Degree in Science, Chemistry, Biology or related field of study

Minimum of 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

Other Qualifications:

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

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.

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 positions 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.

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.