Quality Investigations Specialist II

Curia Aalborg ApS; Albuquerque (NM); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Benefits

Vacation and holidays

Career advancement

Education reimbursement

401k program

Learning platform

And more!

Job summary

Curia is seeking a Quality Investigations Specialist in Albuquerque, NM. The role provides QA oversight and SME for cGMP investigations, working with Quality and Operations to keep facilities ready for inspections and ensure right-first-time manufacturing.

The position supports complaints, deviations, and failure investigations, performs root-cause analysis, and helps update SOPs. Candidates should have 3+ years in QA/regulatory roles and relevant degrees.

Qualifications

• Bachelor's or Associate's degree in science-related field preferred.
• Minimum of three (3) years of experience in quality assurance and/or regulatory experience in the Pharmaceutical industry with understanding of GMP-related requirements.

Responsibilities

• Provides QA oversight/leads and subject matter expertise for GMP investigations.
• Ensures readiness for regulatory and customer inspections through QA oversight of facilities and processes.
• Supports product complaints, deviations, and failure investigations.
• Performs root cause analysis and implements corrective actions.
• Recommends changes to SOPs and assists during FDA and other inspections.

Skills

Mentorship

Collaboration

Change champion

Safety awareness

Attention to detail

Education

Bachelor's Degree in Science, Chemistry, Biology or related field

Associate's Degree in Science, Chemistry, Biology or related field

Job description

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 CURIA's 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:

• Bachelor's Degree in Science, Chemistry, Biology or related field of study, preferred
• Associate's 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

Other Qualifications:

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

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.

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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