Quality Operations Specialist III

Curia • Albuquerque, NM

4d • Onsite

About The Position

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.

Requirements

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

Nice To Haves

• Experience working with third-party contract manufacturing in the pharmaceutical industry, strong preferred

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
• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior