Description
SUMMARY OF POSITION :
Perform advanced quantitative and qualitative analyses of pharmaceutical components, in-process material, finished good product, and / or stability product.
Depending on the department to which the incumbent reports some of the functions listed may not be applicable.
ESSENTIAL FUNCTIONS :
1. Perform advanced level analytical laboratory tests (such as potency, purity, related substances, uniformity, dissolution, moisture, etc.
in accordance with approved methodology and cGMP, FDA, and DEA regulations, including :
a. Set-up, adjustment, calibration, operation, repair and troubleshooting of laboratory equipment and instruments, as well as any associated software.
b. Preparation of solutions, solvents, and mobile phases.
c. Accurate preparation, collection, weighing, and analysis of samples and reference standards, and determination of conformance of results to approved specification limits.
d. Accurate and timely documentation of all procedures, calculations, and results.
e. Must be able to independently perform and adequately document intermediate level investigations for out-of-specification / out-of-trend results.
2. Complete assignments in a timely manner, thereby promoting team achievement of departmental attainment goals.
3. Support, identify, and execute efficiency and throughput improvements.
4. Support, identify, and execute continuous quality improvement initiatives.
5. Execute / implement special projects under own initiative.
6. Capable of training personnel in the QA Analyst I, Quality Tech I, and Quality Tech II positions.
Associates or Bachelors Degree in Chemistry or equivalent
A minimum of six years of relevant experience is required in conjunction with an Associates Degree in Chemistry / equivalent.
A minimum of four years of relevant experience is required in conjunction with a Bachelors Degree in Chemistry / equivalent.
Compensation - $46,000.00 - $55,000.00
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