Perform entry level testing within the QC Lab. Scope includes retain inspections, entry level /microbiological testing and utility sampling.
Perform routine laboratory tasks such as Utility/EM sample collections, execution of equipment work orders,, reading of environmental monitoring samples, bioburden testing, level one audits, daily pH meter and balance calibration, etc. Perform tasks associated with ordering laboratory supplies and maintaining laboratory equipment. Author SOPs and deviations.
Follow and work in accordance with company policies, SOPs and cGMP standards to ensure compliance with all applicable regulations. Identify atypical events or potential problems and communicate these situations with appropriate personnel.
location: Marietta, Pennsylvania
job type: Contract
salary: $18.32 - 21.55 per hour
work hours: 9 to 5
education: High School
- Perform utility sampling as per established procedures. Perform associated sample reads/testing.
- Generate all paperwork and labels associated with sampling to meet SOP requirements.
- Collect PEMS data.
- Perform EM sampling reading and microbiological tests in compliance with current SOPs and GMPs. All testing must be completed to satisfy established timelines and all applicable regulations.
- Author deviations and SOPs.
- Responsible for maintaining and ordering sufficient reagents and supplies, ordering equipment and maintaining the equipment in good working conditions in a calibrated and validated status.
- Performing routine laboratory tasks such as safety shower/eyewash checks, autoclaving materials, performing glass-wash and stocking supplies, daily pH meter and balance calibration, etc.
- Ensure labs are in a 'GMP, safe, analytical-testing readiness' state.
- Assure that all required documentation including records and logs, is complete and accurate according to the current GMPs. File and archive laboratory records and data in accordance with GMPs and SOPs.
- Communicate and report status of operations as well as variances to supervisors.
- Take appropriate actions and escalate issues immediately.
- High School Degree; Assoc. or B.S. preferred
- Prefer two years GMP laboratory experience (microbiology) or Assoc. or B.S. with minimum of one year GxP experience
skills: SOP, Microbiology, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.