Quality Operations Specialist III - Albuquerque - curiate

Description

Quality Operations Specialist III in Albuquerque, NM

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

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 with matching contributions
• Learning platform
• And more

Summary

The Quality Operations Specialist III is an essential part of the Quality Operations team and is responsible for QA oversight, review, and quality approval of large-scale expansion project deliverables. This role supports QA activities related to equipment, facilities, processes, computerized systems, and manufacturing projects, including facility expansion and new line installations, as well as commercial manufacturing operations.

The role provides clear guidance on quality requirements consistent with cGMPs, regulatory expectations, and industry best practices, ensuring objectives are met within timeline constraints. Additionally, this position helps establish and maintain cross-departmental relationships to enhance overall compliance and efficiency. The Specialist III supports facilities, validation, manufacturing, and engineering activities while providing QA input and guidance for the review and approval of regulated, controlled documents, including but not limited to SOPs, validation protocols, commissioning documents, deviations, change controls, work orders, and Validation Master Plans.

Responsibilities

• Serve as a quality resource and approving authority in support of validation, change control, work orders, and other related documents as the quality approver. Support departmental strategic goals to assure the highest quality standards and regulatory compliance.
• Provide quality compliance direction for validation and manufacturing activities. Serve as the quality liaison by providing compliance requirements for new product opportunities, including new equipment and technology.
• Direct process improvements and goals for Curia using current regulations and demonstrated best practices. Serve as a quality liaison between the site and customers or regulatory agencies during facility audits/inspections.
• Support effective and efficient continuous quality and cost improvement efforts.
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Qualifications

• Bachelor's degree (BS or BA) in a scientific or related field from a four-year accredited college or university
• Minimum of five (5) years of progressively increasing responsibility in the pharmaceutical or biologics industry, with experience in validation activities, regulatory compliance, and/or quality. Must also have relevant experience in change control, deviations, and CAPA
• Demonstrated understanding of laboratory, manufacturing, packaging, regulatory affairs, compliance, and quality assurance requirements for biological and aseptic drug product manufacturing
• Experience working with third-party contract manufacturing in the pharmaceutical industry, strong preferred

Supervisory Responsibilities

This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

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

Provide quality oversight and approval related to validation of processes, utilities, facilities, and equipment. Provide quality validation oversight to facility, utility, and equipment upgrades.

• Provide review and approval for qualification, validation, re-qualification, and re-validation documents for equipment and manufacturing process protocols, deviations, and final report.
• Collaborate with validations and project teams on the coordination and prioritization of validation activities.
• Provide QA oversight of the writing, updating, and maintaining of pertinent validation master plans for the facility.
• Provide QA oversight for the writing, updating, and maintaining of pertinent validation technical packages for product submissions.
• Communicate with clients regarding changes to facilities, processes, and procedures.
• Provide plant management with data and information appropriate to reduce the potential for regulatory action and assist in Curia productivity management.
• Keep plant management advised concerning agency, customer, and internal audit compliance commitments.

Provide training and technical expertise on quality systems, especially related to facilities, validation, engineering and cGMPs

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.

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 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.

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