What are the responsibilities and job description for the Quality Investigations Specialist II position at Xtalks?
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
This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
Responsibilities
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.
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!
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
- 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
- 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
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
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.