Job Title: Compliance Specialist lll, 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.

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!

Essential Duties and Responsibilities:

• Supports Operations and Quality by rendering advice/opinions on compliance with regulatory matters

• Provides regulatory assessments of proposed changes, to the facilities or processes, and evaluates the compliance aspects of new products introduced to the facility

• Facilitates updates to the facility Quality Risk Management Plan (QRMP) and participates with team members to develop product-specific QRMPs as part of new product introduction

• Supports customer filings for marketing authorizations by generating portions of the CMC sections of Abbreviated New Drug Applications (ANDA)/New Drug Applications (NDA), and also generates supplements to marketing authorizations as required

• Generates routine documentation such as declarations, statements, and certifications regarding the site’s compliance with cGMPs, use of latex, BSE/TSE, OVI, BPA, etc., for domestic and foreign agencies

• Generates position papers or formal communications that may serve as customer notifications, to address facility modifications/shutdown activities, and new product introductions.

• Generates and amends the facility’s Type V master files (e.g., Drug Master File, Biologics Master File, and Veterinary Master File) with U.S. FDA and the Site Master/Reference File for foreign agencies

• Files documentation for the state, local, national licenses, permits, establishment registrations, etc., for renewal to maintain the facility’s compliance with applicable laws and regulations.

• Establishes quality agreements with customers, including negotiation of terms/responsibilities and manages revisions to existing quality agreements.

• Monitors compliance with the terms of the customer-specific quality agreement as it relates to regulatory matters

• Provides compliance/regulatory approval for new/revised printed components. Supports the site during the state, government, and foreign inspections

• Read/interpret SOPs to ensure compliance

• Maintain up to date trainings

• Other duties as assigned

Education and/or Experience:

Bachelor’s degree in Science or related field of study

Minimum of five (5) years’ experience in quality assurance, preferred

Minimum of five (5) years’ experience in a bio/pharmaceutical manufacturing environment, 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

• Proficient in problem-solving techniques and demonstrates the ability to troubleshoot with limited supervision. Technical resource for routine issues about compliance with regulatory requirements as needed. Review reports and documents proficiently for completeness and accuracy. Ability to organize time for multiple tasks and respond to high-priority tasks when necessary.

• Delivers assigned tasks on time. Independently read pharmaceutical publications to be apprised of industry trends. Attend industry led-training courses, as appropriate.

• A reasonable degree of initiative thinking to resolve problems is required. The work is routine to moderately complex but covered by well-defined policies, procedures, and regulatory guidance. This position will require the ability to resolve problems, requiring some independent judgment.

• Actions to be taken will be discussed with the supervisor before resolving non-routine problems. Knowledge of technical writing and technical terminology including technical writing skills. Ability to assess and communicate regulatory risks.

• Knowledge of aseptic processing and regulatory and industry guidelines and requirements. Ability to train and counsel Quality professionals and production personnel. Knowledge of cGMPs, GDPs, as well as, sound quality and regulatory principles consistent with ‘best practices.’

• Leadership qualities required. Attention to detail required. Ability to read, understand, interpret and apply technical writing and instructions. Good verbal and written communication skills.

Other Qualifications:

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

May be required to obtain and maintain gowning certification

May be required to obtain and maintain media qualification

May be required 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.