Medasource ยท 1 day ago
CON QC EM Technician
Concord, NC
Contract
Onsite
Entry, Mid Level
$25/hr - $30/hr
2+ years expMedasource is seeking a QC Environmental Monitoring Technician to support parenteral manufacturing operations. The role involves performing routine environmental monitoring and clean utility sampling to ensure compliance with cGMP requirements and maintain a controlled manufacturing environment.
Health CareMedical
Hiring Manager
Lia Burnell
Responsibilities
Adhere to and promote compliance with cGMP regulations, Quality Systems, and Good Documentation Practices (GDP)
Perform routine environmental monitoring of classified manufacturing areas in support of both routine operations and Environmental Monitoring Performance Qualification (EMPQ) activities
Conduct clean utility sampling and analysis, including:
Compressed air
Potable water
Purified water
Water for Injection (WFI)
Clean steam
Support manufacturing and QC laboratory operations by providing accurate and timely environmental monitoring data
Enumerate, review, and document environmental monitoring results using LIMS or other laboratory data systems
Perform Second Person Verification (SPV) of environmental monitoring data on a routine basis
Participate in continuous improvement initiatives and quality-focused projects
Assist in the development, revision, and maintenance of SOPs and Work Instructions as needed
Adhere to and promote compliance with all site safety policies and procedures
Qualification
Required
High School Diploma or equivalent required
Minimum of 2 years of experience performing Environmental Monitoring in a GMP-regulated pharmaceutical manufacturing environment
Hands-on experience with environmental monitoring techniques, including: Viable surface monitoring, Viable air monitoring, Non-viable air monitoring, Compressed air sampling, Water and clean utility sampling and analysis
Experience working with laboratory systems such as LIMS, LES, and/or MODA
Ability to work in laboratory and cleanroom environments while wearing appropriate PPE
Ability to gown into facility-specific cleanroom attire
Ability to stand or walk for extended periods and perform repetitive tasks
Ability to lift, push, pull, and carry up to 30 pounds
Ability to work 12-hour shifts
Flexibility to work day or night shifts, particularly during training and startup phases
Preferred
Associate degree preferred
Prior experience supporting aseptic or parenteral manufacturing operations strongly preferred
Strong understanding of cGMP regulations and regulatory compliance expectations
Experience performing environmental monitoring within filling isolators or Restricted Access Barrier Systems (RABS)
Ability to train and mentor junior Environmental Monitoring Technicians
Strong written and verbal communication skills
Proven ability to collaborate effectively in a cross-functional team environment
Company
Medasource
Medasource is a hospital & health care company specializing in population health management and clinical engineering services.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Abimbola ojo
EPIC OPTIME/ ANESTHESIA Consultant at Ascension
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