Manufacturing Quality Assurance Analyst III
Curia · Albuquerque
Manufacturing Quality Assurance Analyst III, 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 Manufacturing Quality Assurance (MQA) Analyst III is a senior-level quality professional responsible for providing independent, floor-based quality oversight of sterile manufacturing operations. This role serves as Quality’s primary presence in manufacturing areas, proactively monitoring operations, reviewing records and logbooks, assessing adherence to aseptic requirements and identifying compliance concerns before they impact product quality or manufacturing performance.
Working closely with Manufacturing, Microbiology, Validation, Training, Technical Operations, and other support functions, the MQA Analyst III evaluates manufacturing activities in real time, assesses operational and quality risks and provides timely quality decisions to support compliant execution of manufacturing operations. This position requires strong technical expertise in sterile manufacturing, aseptic processing, contamination control and cGMP compliance, as well as the ability to identify potential issues, determine risk to product quality and manufacturing operations and proactively drive resolution of quality concerns.
Essential Duties and Responsibilities:
- Provide routine floor-based quality oversight of sterile manufacturing operations to ensure compliance with cGMP requirements, approved procedures, aseptic practices and site quality standards.
- Maintain a visible quality presence in manufacturing areas and independently monitor manufacturing activities, personnel practices and operational execution.
- Perform real-time review of batch records, logbooks, equipment records and supporting documentation to identify errors, omissions, discrepancies and data integrity concerns before completion of manufacturing activities.
- Review and verify critical manufacturing parameters, sterilization records and related process documentation to ensure compliance with approved procedures and validated requirements.
- Conduct line clearances, room inspections, area walkthroughs, and operational readiness assessments prior to and during manufacturing activities.
- Evaluate manufacturing operations for compliance with contamination control, aseptic processing, gowning, cleaning, disinfection and sterile manufacturing requirements. Identify, assess, document, and promptly escalate quality events, procedural deviations, documentation errors, compliance concerns, and potential product quality impacts.
- Perform risk assessments and provide independent quality decisions regarding manufacturing events, documentation discrepancies, process deviations and operational issues.
- Assess the potential impact of manufacturing events on product quality, patient safety, sterility assurance, regulatory compliance and manufacturing operations.
- Partner with Manufacturing and supporting departments to proactively resolve quality and compliance issues before they result in product impact, batch delays or manufacturing disruptions.
- Provide quality oversight and support during manufacturing interventions, aseptic processing activities, equipment preparation, sterilization activities and troubleshooting events
- Ensure manufacturing activities are executed in accordance with Standard Operating Procedures (SOPs), approved batch records and regulatory requirements.
- Author and support investigations, including root cause analysis, product impact assessments, and the development of corrective and preventive actions (CAPAs).
- Review and approve manufacturing documentation and facility release documentation in accordance with approved procedures.
- Support audit and regulatory inspection activities and serve as a subject matter resource for sterile manufacturing quality oversight.
- Maintain qualifications required to support quality oversight activities across all assigned manufacturing operations.
- Provide quality coverage across all productions shifts as required to support 24-hour manufacturing operations.
- Promote a safety-focused, patient-centered, and right-first-time quality culture.
- Perform other duties as assigned.
Supervisory Responsibilities:
- This position has no supervisory responsibilities
- Provides functional quality oversight and guidance to manufacturing personnel to ensure compliance with cGMP requirements, aseptic processing standards and approved procedures.
- Exercises independent quality decision-making authority within the scope of assigned responsibilities and established quality systems.
- May support the onboarding and training of new MQA personnel and serve as a subject matter resource for manufacturing quality oversight activities.
Education and/or Experience:
Required
- High School Diploma or GED.
- Minimum 3 years of quality assurance experience supporting sterile pharmaceutical manufacturing and/or aseptic processing.
- Experience providing floor-based quality oversight in a GMP manufacturing environment.
- Experience reviewing batch records, logbooks, equipment records and manufacturing documentation.
- Knowledge of aseptic processing, contamination contro, sterilization processes and cGMP requirements.
- Ability to independently assess quality riks and make quality decisins within established procedures and quality systems.
Preferred
- Bachelor’s degree in a scientific discipline.
- Experience supporting aseptic filling, sterile processing.
- Experience supporting regulatory inspections and quality audits.
Language /Communication Skills:
- Ability to communicate quality requirements and compliance concerns effectively to manufacturing and operational personnel.
- Ability to communicate and defend independent quality decisions in a professional manner.
- Technical document comprehension.
- Technical writing skills
- Interdepartmental communication
- Proficient in MS Word, Excel, Outlook
- Proficient in TWD
Mathematical Skills:
- Basic algebra
- Basic statistics
Reasoning Ability:
- Problem solving experience
- Decision Making
Other Qualifications:
- Ability to work flexible schedules, including off-shiftts, weekends, holidays and extended hours as required to support manufacturing operations
- Demonstrated ability to exercise sound quality judgment in fast-pced manufacturing environments.
- Must pass a background check
- Must pass a drug screen
Physical Demands:
- Ability to remain on the manufacturing floor for extended periods of time, including standing and walkng for prolonged durations.
- Ability to enter classified manufacturing areas and perform aseptic gowning requirements.
- Ability to climb stairs, bend, crouch and access manufacturing equipment and documentation as required.
- Ability to visually inspect manufacturing operations, equipment, documentation and production records.
- Specific vision abilities required by this job include close vision, distance vision, and depth perception with or without corrective lenses.
Work Environment:
Regularly works in sterile manufacturing and controlled GMP environments requiring adherence to gowning, aseptic behavior and contamination control requirements.
Routinely exposed to manufacturing operations, production equipment, cleaning and sanitization agents and other materials commonly found in pharmaceutical manufacturing environments.
Responsible for providing quality oversight across manufacturing shifts as required by business needs.
Significant time is spent in production areas performing real-time quality oversight activities.
The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions.
It is common to hear conversational noise in the background. The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required.
Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment. The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.
Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.
All environments may be subject to working with or being exposed to cleaning agents.
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.
The Manufacturing Quality Assurance (MQA) Analyst III is a senior-level quality professional responsible for providing independent, floor-based quality oversight of sterile manufacturing operations.