4933 Analyst, QC I
Perform, under direct supervision, chemical analyses of incoming raw materials under cGMP to meet specified timelines.
Evaluate results and trend data.
Maintain raw materials log and control of laboratory inventories.
Coordinate and track outside laboratory testing activities.
Participate in the preparation of investigations, summaries and reports.
Maintain the laboratory in an inspection ready state.
Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary.
On rare occasion, provide on call coverage to perform off-shift emergency testing in support of manufacturing.
Other duties assigned.
Must have a positive, team minded personality.
At least one year in a cGMP laboratory and quality control experience preferred, but not required.
Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory. Practices preferred Demonstrated working knowledge related to specific functional activities.
Ability to perform most tasks with moderate supervision.
Computer literacy is required.
Experience with Microsoft Word and Excel required; experience with Labware LIMS, O365 a plus.
Must have excellent record keeping, written and verbal skills.
Work in a GMP laboratory and be compliant with the laboratory procedures.
May work with biohazardous materials, hazardous chemicals, and radioactive materials.
Comfortable lifting 50 pounds.
Ability to work independently and to deal with multiple tasks.
May be required to work second shift, overtime, weekends and holidays.
Moderate supervision and minimal guidance should only be necessary for specific ad hoc assignments.
Organizational skills as well as good written and verbal communication skills essential.
Must work effectively as a member of the team.
Must have a Quality service attitude and be willing to work additional hours to meet deadlines and requirements.
Experience in a cGMP laboratory; quality control experience preferred.
Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices preferred.
Familiarity/experience with Compendial testing (USP, EP, JP) preferred.
Familiarity/experience with Labware LIMS preferred.
B.S./B.A. in Science (major in biology-biochemistry-chemistry or related field) with at 0 – 1 years of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.