Job Information
Curia Environmental Monitoring Analyst II (2nd shift 3-11:30 pm) in Burlington, Massachusetts
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries
The EM Analyst II performs microbiological activities in support of production. The EM Analyst performs environmental monitoring of the clean rooms for microbial and particulate counts.
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!
Essential Duties and Responsibilities:
Perform plate enumeration and incubation
Prepare and send plates out for identification
Perform sampling of water ports and submit for analysis
Perform Environmental Monitoring (EM) of the clean rooms (under USP and EU specifications) both viable and non-viable monitoring for routine and batch related sampling as needed
Maintain Cleanroom gowning qualification to Grade A/B
Perform microbial plating of personnel during manufacturing and personnel qualification.
Provide guidance to individuals in real time on Aseptic Technique on the floor
Perform non-routine EM such as quarterly compressed gas testing or investigational testing
Collect data from the particulate monitoring system and audit system to ensure appropriate sensors are activated.
Initiate and Investigate OOS/OT or Environmental Monitoring Excursion Investigations
Propose appropriate CAPAs as a result of Investigating Excursions or Deviations
Perform Data entry in order to maintain appropriate databases
Compile data and Review Batch records in order to adhere to specified Turn-around-times
Perform cGMP documentation, review routine sampling worksheets for documentation errors.
Maintain current training status on equipment, procedures, and test methods.
Supervisory Responsibilities:
This job has no supervisory responsibilities.
Education and/or Experience:
High School Diploma for analyst and (3+) years of related experience.
Computer proficiency (Windows environment).
Previous experience with pharmaceutical cleanroom environments a plus.
Language Skills:
Ability to write reports and correspondence. Ability to speak effectively before groups of customers or employees. Proficient and comfortable in business meetings and work related social and business development situations. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals and communicate this information to others.
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:
Perform this job successfully, an individual should have knowledge of Manufacturing software; Spreadsheet software and Word Processing software.
Other Skills and Abilities:
Facilitate the revision and release of all controlled documents
Facilitate mandatory reviews of SOP
Provide oversight for projects to update/maintain official document templates
Other Qualifications:
Must pass background check
Must pass drug screen
Physical Demands:
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.
Work Environment:
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.
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.
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