Required Skills and Experience
· Solid microbiology foundation with experience in performing product testing
· Proven technical writing skills (SOPs, protocols)
Desired Skills and Experience
· Experience in the pharmaceutical/biotechnology industries preferred
· Experience with environmental monitoring and water testing preferred
Responsibilities
· Analyze samples and compile meaningful data
· Perform Investigations and prepare/respond to CAPA
· Review, revise Test Procedures/Standard Operating Procedures
· Ad Hoc work
· Rotational on-call assignments
:
· Receive, verify & Log in samples
· Return templates and shipping paperwork when and where appropriate
· Compile and trend data
· Prepare and ship materials offsite for ID/testing (when applicable)
· Environmental monitoring
· Stock culture management and quality control of same
· Biological indicator management
· Bioburden testing
· Water sampling
· Microbiological media management and quality control of same
· Sterilization activities
· Research experiments as deemed appropriate by Merck management
· Method Validation/Qualification
· Other microbiological activities
· Rotational on-call assignments for responding to alarms
:
· Execute “Before-Use” calibrations prior to performing testing
· Review calibration data within the ELN
· Prepare and submit equipment for calibrations (offsite or onsite)
· Complete calibration/PM paperwork
· PROCAL Entries
:
· Prepare GMP documentation as requested by management
· Perform laboratory sanitizations and ensure cleanliness of laboratory workspace
· Perform equipment sanitizations (incubators / hoods / refrigerators)
· Purchase supplies (GMP)
· Prepare and send documents to Records Center
:
· Initiate, facilitate, and perform Investigations and NOEs (Notice of Event-NOE) for Environmental samples [NOE for Microbiological Environment Event (MEN)]
· Inform management of non-conforming events
:
· Participate in audits (Regulatory, In-house, Corporate)
· Participate in self-inspections and safety inspections
· Retrieve data when requested by Microbiology management
Job Types: Full-time, Contract
Pay: $23.50 - $36.00 per hour
Expected hours: 40 per week
Benefits:
Schedule:
Education:
Shift availability:
Ability to Commute:
Work Location: In person