QC Environmental Monitoring Technician

39 minutes ago

Concord NC, United States Medasource Full time

Job Title: QC Environmental Monitoring Technician Department: Quality Control
Position Overview:
The QC Environmental Monitoring Technician is responsible for supporting parenteral manufacturing operations through routine environmental monitoring of classified manufacturing areas, as well as conducting clean utility sampling and analysis within both manufacturing and QC laboratory facilities. This role plays a critical part in ensuring compliance with cGMP requirements and maintaining a controlled manufacturing environment to support the production of safe and effective pharmaceutical products.

Key Responsibilities:
Adhere to and promote compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices (GDP).
Perform routine environmental monitoring of classified manufacturing areas to support both standard operations and Environmental Monitoring Performance Qualification (EMPQ) activities.
Conduct clean utility sampling and analysis, including but not limited to:
Compressed air
Potable water
Purified water
Water for Injection (WFI)
Clean steam
Support manufacturing and laboratory activities by providing timely and accurate environmental monitoring data.
Enumerate, review, and document sampling results in LIMS or other laboratory data systems.
Perform Second Person Verification (SPV) of environmental monitoring results on a routine basis.
Participate in continuous improvement projects and quality initiatives.
Assist with authoring and updating Standard Operating Procedures (SOPs) and Work Instructions as required.
Adhere to and promote compliance with all site safety standards.

Minimum Requirements:
~ High School Diploma or equivalent required; Associate degree preferred.
~2+ years of experience performing Environmental Monitoring in a GMP pharmaceutical manufacturing environment, preferably supporting aseptic or parenteral production.
~ Demonstrated 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 with laboratory systems such as LIMS, LES, and/or MODA.


Preferred Qualifications:
Strong understanding of cGMP requirements and regulatory compliance.
Experience performing environmental monitoring within filling isolators or restricted access barrier systems (RABS).
Ability to train and mentor junior Environmental Monitoring Technicians.
Strong verbal and written communication skills.
Ability to work effectively with cross-functional teams.

Physical & Work Environment Requirements:
Ability to work in laboratory and cleanroom environments while wearing appropriate PPE.
Ability to gown into facility-dedicated cleanroom attire as required.
Ability to stand or walk for extended periods and perform repetitive tasks.
Ability to lift, push, pull, and carry up to 30 pounds.

Work Schedule & Travel:
Ability to work 12-hour shifts.
Flexibility to work day or night shifts as required, especially during training and startup phases.
Role may initially support project/startup activities and transition into a routine operational support role.

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