QC Chemist I, Raw Materials

Quality Control Raw Materials Chemist IThe Quality Control Raw Materials Chemist I performs testing using a variety of analytical techniques. The successful candidate ensures that testing and documentation is compliant with GMP regulations and internal procedures. The ideal candidate will additionally possess superior communication skills. The position will be operating within a GMP environment for a Quality Control CDMO.Essential FunctionsPerform testing of raw materials, packaging components, and other samples.Well versed with various laboratory techniques, including, but not limited to HPLC, GC, titrations, and various raw materials testing techniques.Conduct routine analytical experiments using established analytical methods and procedures.Data entry into reports, as directed by senior laboratory personnel.Verify simple transcription processes, such as checking accuracy of calculations and reviewing daily equipment verifications for compliance.Support testing for investigations for OOS, OOT, and aberrant results and troubleshooting.Review and maintain laboratory notebooks.Ensure data collected is processed and submitted for review in a timely manner.Maintains laboratory inventory of chemicals, standards, and consumables and orders materials as necessary.Aid in investigations for OOS, OOT, and aberrant results and troubleshooting by assisting in root cause determination.Generate and/or review shipping paperwork for third party testing and prepare samples for shipment.Create purchase requisitions for lab supplies and third-party testingPerform weekly laboratory audit inspectionsPerform sampling of raw materials as neededOther duties as assignedSupervisory ResponsibilitiesDirect Reports: NoneIndirect Reports: NoneKey RelationshipsManufacturing OperationsQuality AssuranceAnalytical R&DProgram ManagementTravel RequirementsNoneEducation and ExperienceMinimum BA or BS in a scientific discipline requiredMinimum 2 – 4 years in a Quality Control setting for Raw MaterialsKnowledge, Skills, and AbilitiesKnowledge of cGMPsGood communication, organization and computer skills are required.Knowledge of Empower and Microsoft Office (Excel, Word) is required; LIMS knowledge is desired.Ability and willingness to work additional hours as required by business needsExperience with testing per USP, EP, BP, and JP monographs.Ability to interpret various compendial guidelines to ensure specifications meet regulatory requirements.Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators, Coulometric Karl Fischer Titrators, Melting Point Apparatus, Muffle Furnace, UV-Vis, Refractometers, and Particle size.Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholdersAbility to work with modest supervisionAble to multi-task productively, applying time management processes and procedures effectively.Self-directedPhysical Demands and Work EnvironmentWhile performing the duties of this job, there may be certain physical demands required for the position.Requires constant standing, walking, seeing, gripping, & hearingRequires frequent sitting, bending, pushing, & reachingRequires constant carrying under 20 LBS, occasionally 20 – 60 LBS.Requires frequent lifting & pulling under 20 LBS, occasionally 20 – 60 LBS.Requires occasional twistingOther DutiesYou may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.