What are the responsibilities and job description for the Aseptic Core Monitor I position at Curia?
Job Description
Aseptic Core Monitor I
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
We proudly offer
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
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
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The essential physical demands will vary for each Curia position.
All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.
Work Environment
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.
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 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.
Aseptic Core Monitor I
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
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
- Learning platform
- And more!
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
- 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
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)
- 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
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The essential physical demands will vary for each Curia position.
All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.
Work Environment
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.
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 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.
