Production Specialist Iii

Production Specialist in Albuquerque, NM
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Production Specialist III serves as a subject matter expert, providing technical support to the production team.
This position leads efforts to achieve on-time metrics, continuous improvement, and "right first time" initiatives.
This role is also responsible for serving as a liaison for commercial products, New Product Introduction (NPI), and customer relations, as they pertain to manufacturing according to current Good Manufacturing Practices (cGMP).
Additionally, the Production Specialist III is expected to solve complex problems and contribute significantly to process improvements.
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:
* Act as a subject matter expert in manufacturing, representing the department in daily meetings, including New Product Introduction (NPI), Root Cause Analysis (RCA), customer audits, customer calls, and Change Control Board (CCB) activities.
Independently attend and support all customer meetings, ensuring comprehensive manufacturing representation.
* Take full ownership of deviations, Corrective and Preventive Actions (CAPAs), and change controls, driving the process with minimal guidance to ensure timely and effective resolution.
Facilitate Root Cause Analyses (RCAs) for deviations and safety events as required, using your expertise to solve complex issues.
* Provide manufacturing signoff on Master Batch Record (MBR) and Standard Operating Procedure (SOP) revisions.
Create, revise, and maintain SOPs and other critical documents, ensuring they reflect the latest process improvements and compliance requirements.
* Participate in NPI meetings, offering in-depth manufacturing oversight and engagement to ensure that new products meet production standards and timelines.
* Lead efforts to ensure on-time closure of regulatory commitments, deviations, CAPAs, and velocity reports, utilizing your knowledge to streamline processes and resolve issues efficiently.
* Spearhead activities aimed at improving Environmental Monitoring (EM) health within the facility, ensuring compliance with regulatory standards and enhancing overall manufacturing conditions.
* Contribute to and lead continuous improvement projects, applying your extensive knowledge to enhance manufacturing processes and drive operational excellence.
* Support shift-wide training initiatives, ensuring that all team members are up-to-date with required trainings and are able to interpret SOPs to maintain compliance with cGMP standards.
* Perform all responsibilities with a high degree of independence, receiving minimal guidance and using your expertise to proactively address challenges and opportunities.
* Flexibly take on additional responsibilities as needed, contributing to the overall success of the manufacturing operations.
* Read/interpret SOPs to ensure compliance
* Maintain up to date trainings
* Other duties as assigned
Education and Experience:
* Bachelor's degree in Science, Engineering, or related field of study; or high school diploma with minimum of five (5) years' related work experience
* Pharmaceutical/Biotechnology industry experience in an FDA-regulated environment strongly preferred
* Demonstrates strong attention to detail
* Must be available to work any shift
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.
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
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.