Aseptic Core Monitor I

Curia • Albuquerque, NM

7h

About The Position

The Aseptic Core Monitor I (ACM I) is an intermediate-level role within the MQA On the Floor functional unit, a multi-tier, multifunctional team of Analysts, Specialists, and Core Monitors. The team supports safe work practices, regulatory and Standard Operating Procedure (SOP) compliance, and schedule adherence through expertise in current Good Manufacturing Practices (cGMP) and aseptic processes.

The ACM I partners with manufacturing to support oversight of aseptic processes and tier-one decision-making. The role requires effective interpersonal communication, conflict resolution, critical thinking, decision-making, and the ability to explain complex concepts and teach others. The ACM I collaborates routinely with management, frontline manufacturing and support technicians, and senior MQA OTF team members, and escalates urgent matters to facilitate decisions on a path forward.

This role has no supervisory responsibilities, though it may involve mentoring, guiding, and advising. The position requires reading and interpreting technical, safety, and regulatory documents; strong written, verbal, and presentation skills; mathematical and reasoning abilities; and effective use of manufacturing, internet, and Microsoft Office software. Candidates must pass a background check and drug screen, may be required to pass occupational health screening, and must be able to obtain and maintain gowning certification and media qualification. Wearing a respirator may be required.

Requirements

• Associate’s degree in Microbiology or a related field and at least three years of previous professional experience.
• Industrial GMP experience in an FDA-regulated pharmaceutical environment.
• Aseptic processing experience, including proficiency in aseptic gowning qualifications.
• Ability to read and interpret safety instructions, SOPs, technical procedures, and governmental regulations.
• Strong written and verbal communication and presentation skills.
• Ability to perform arithmetic operations across units of measurement using whole numbers, fractions, decimals, and percentages, and a strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, draw valid conclusions, interpret technical instructions in mathematical or diagram form, and work with abstract and concrete variables.
• Technical foundation and ability to use manufacturing and internet software and Microsoft PowerPoint, Excel, Word, and Outlook.
• Strong attention to detail.
• Must pass a background check and drug screen.
• May be required to pass occupational health screening.
• Must be able to obtain and maintain gowning certification and media qualification.
• May be required to wear a respirator.

Nice To Haves

• Bachelor’s degree in Microbiology or a related field and at least two years of previous professional experience.
• Basic quality tool experience, such as Pareto charts, histograms, cause and effect, and root cause analysis.

Responsibilities

• Perform daily visual audits.
• Communicate effectively.
• Make decisions.
• Assess risks.
• Deliver coaching and training.
• Record and track data.
• Review documentation.
• Collaborate within and across departments.
• Read and interpret SOPs to ensure compliance.
• Maintain up-to-date training.
• Provide guidance and mentorship to team members.
• Foster a collaborative and positive work environment.
• Champion change.
• Promote a safe and healthy work environment by identifying and addressing hazards, following safety protocols, participating in safety training, and fostering awareness and responsibility.
• Perform other duties as assigned.

Benefits

• Generous benefit options, available from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree