Job Description

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.

• Requires constant standing, walking, seeing, gripping, & hearing
• Requires frequent sitting, bending, pushing, & reaching
• Requires constant carrying under 20 LBS, occasionally 20 – 60 LBS.
• Requires frequent lifting & pulling under 20 LBS, occasionally 20 – 60 LBS.
• Requires occasional twisting

Other Duties

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

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