- Professional
- Optionales Büro in Huntsville
Job Summary - a concise overview of the job | ||
A Chemist II evaluates the chemical and physical properties of various raw materials and finished products under cGMP guidelines. Utilizes established methods and procedures and laboratory equipment to perform the analytical testing and ensure all products released are safe and efficacious. Performs method transfer and validations, and conducts laboratory investigations. | ||
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. | ||
The Chemist II operates within the Analytical Quality Control Laboratory, under the direction of the Quality Organization. The Chemist II has no budget/spend authority, but may act as SME in the selection of materials and equipment. | ||
| ||
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time | ||
Accountability | Responsibilities | % of Time |
Floor Operations |
| 75% |
Non-Conforming Events |
| 15% |
Process Improvement |
| 10% |
Compliance |
| continuous |
Safety |
| continuous |
Total | 100% | |
| ||
Qualifications | |
Education & Experience | Minimal acceptable level of education, work experience and certifications required for the job |
| |
Knowledge | Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. |
| |
Skills & Abilities | Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. |
| |
Physical Requirements | Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. |
| |
