Position Summary – The 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 Functions
Perform 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 testing
Perform weekly laboratory audit inspections
Perform sampling of raw materials as needed
Other duties as assigned
Supervisory responsibilities:
Direct Reports: None
Indirect Reports: None
Key Relationships:
Manufacturing Operations
Quality Assurance
Analytical R&D
Program Management
Travel requirements:
None
Education and Experience
Minimum BA or BS in a scientific discipline required
Minimum 2 – 4 years in a Quality Control setting for Raw Materials
Knowledge, Skills, and Abilities
Knowledge of cGMPs
Good 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 needs
Experience 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 stakeholders
Ability to work with modest supervision
Able to multi-task productively, applying time management processes and procedures effectively.
Self-directed
Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position.