Aseptic Core Monitor I

Summary

The MQA On the Floor (MQA OTF) functional unit is a multi-tier, multi-functional team consisting of Analysts, Specialists, and Core Monitors. This team optimizes safe work practices, regulatory and Standard Operating Procedure (SOP) compliance, and schedule adherence through expertise according to the current Good Manufacturing Process (cGMP) and aseptic processes. The Aseptic Core Monitor (ACM) I role is an intermediate level role. The ACM I partners with manufacturing to provide support in the aseptic process oversite and tier one decision making activities.

A successful candidate will demonstrate skills in intrapersonal communication, conflict resolution, critical thinking, decision making and the ability to break down complex concepts and teach them to others. The ACM I must communicate effectively during collaborations with production partners and escalate urgently to facilitate path forward decisions. The ACM I will work collaboratively on a routine basis with management, front line manufacturing/support group technicians and with senior MQA OTF team members.

Essential Duties and Responsibilities

• Perform daily visual audits
• Communicate effectively
• Make Decisions
• Assess risks
• Deliver coaching/training
• Record and track data
• Review documentation
• Collaborate intra and interdepartmentally
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Education and Experience

• Associate’s degree in Microbiology or related field of study with a minimum of three (3) years of previous professional experience
• Industrial GMP experience in an FDA-regulated pharmaceutical environment
• Aseptic processing experience, including proficiency in aseptic gowning qualifications
• Bachelor’s degree in Microbiology or a related field of study with a minimum of two (2) years of previous professional experience, preferred

Supervisory Responsibilities

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

Language Skills

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical Skills

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

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
• Basic quality tool experience (i.e., Pareto charts, histograms, cause and effect, root cause analysis)

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• Must be able to obtain and maintain gowning certification
• Must be able to obtain and maintain media qualification
• May be required to wear a respirator