Some allergens are present in the parenteral plant.
Summary:
The QC Environmental Monitoring Technician will perform routine and investigational environmental monitoring of classified manufacturing, filling, and support areas. Support daily EM laboratory operations.
Responsibilities:
Support production operations by means of EM sampling of classified manufacturing, filling, and support areas and operations personnel.
Support daily EM laboratory operations and process/equipment qualification activities, as necessary.
Ensures compliance with current Good Manufacturing Practice (cGMP) and maintain constant inspection-readiness.
Ensures that data-integrity is maintained
Participate in process streamlining and continuous performance improvement.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
EM Technician requires gowning certification, and repeatedly aseptically gown daily.
Requirements:
High School Diploma or equivalent, Associates degree preferred.
Understanding of cGMP
Excellent written and oral communication skills and ability to collaborate and interact with a team.
Work in a dynamic and fast paced environment with potential to work shifts and weekends.
Must be able to lift 30 pounds and be able to pass, push, and pull to execute specific aspects of job duty.
Must be able to stand / walk for extended periods of time.
Preferred Qualifications:
Environmental Monitoring experience preferred.
Manufacturing or production experience preferred.
Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.
Technical writing and written communication skills are a plus.
Understanding of regulatory standards / requirements for EM.
Knowledge of / familiarity with Parenteral production environments and operations.
Strong computer skills, documentation skills, and attention to detail.
Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
Ability to focus on continuous improvement.
Previous experience with laboratory IT systems including LIMS, LES, and standalone COTS systems.
Understanding of compliance requirements and regulatory expectations for lab systems.