Production Specialist III

4 days ago

Albuquerque, New Mexico, United States curiate Full time
Job Title: Production Specialist III

Curia is seeking a highly skilled Production Specialist III to join our team in Albuquerque, NM. As a subject matter expert, you will provide technical support to the production team and lead efforts to achieve on-time metrics, continuous improvement, and "right first time" initiatives.

Key Responsibilities:
  • Represent the department in daily meetings, including New Product Introduction (NPI), Root Cause Analysis (RCA), customer audits, customer calls, and Change Control Board (CCB) activities.
  • 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.
  • Provide manufacturing signoff on Master Batch Record (MBR) and Standard Operating Procedure (SOP) revisions.
  • 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.
  • Spearhead activities aimed at improving Environmental Monitoring (EM) health within the facility.
  • Contribute to and lead continuous improvement projects, applying your extensive knowledge to enhance manufacturing processes and drive operational excellence.
Requirements:
  • 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.

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.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.

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.

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.

Work Environment:

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

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