A brief summary of the purpose this position must fulfill.
Provide Quality Control laboratory service to fulfill pharmaceutical requirements pertaining to finished products manufactured by or for Kavis Pharma LLC. Assure quality of products through testing, calibration and validation.
Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
To perform this position successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
1. Perform testing of raw materials, in-process product, finished product, and stability of products through bench chemistry and instrumental analysis.
2. Perform analytical method validation/Verification/Transfers.
3. Perform environmental and monitoring testing.
4. Monitor stability storage areas and/or maintain the stability testing program.
5. Replace and standardize solutions used in testing procedures.
6. Perform calibration/performance verification of performance-monitored equipment.
7. Provide support for analytical method validation/transfer and laboratory investigations.
8. Write and revise test methods, standard operating procedures and other Quality Control related documents.
9. Provide support (training, documentation review, etc.) to other chemists as needed.
10. Ensure proper handling of hazardous materials and hazardous waste generated while performing QC activities.
11. Maintain Quality Control laboratory systems to meet cGMP requirements.
12. Perform other duties as assigned, including special projects and housekeeping in the laboratory area.
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
Must possess working knowledge of laboratory instrumentation and analytical testing techniques of bench chemistry and instrumental skills which include (HPLC) High Performance Liquid Chromatograph and (GC) Gas Chromatograph. Experience in regulated pharmaceutical and medical device environment/Quality Control recommended.
Must possess good written and verbal communication skills, interpersonal skills, strong work ethic, consensus gathering skills, organizational skills and a working knowledge of Microsoft Office including Word, Excel and Lotus Notes.
Position functions with supervision.
Minimum of a Bachelor Degree in Chemistry or other life science required. Minimum of 3 years chemistry background is required. However, a combination of experience and/or education will be taken into consideration.
None.
Ability to read and write using the English language. Ability to read and interpret general business documents. Ability to write routine reports and general business correspondence. Ability to work with peers and communicate basic concepts.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio and percent and to draw and interpret bar graphs.
Ability to solve practical problems through standardized solutions that require limited judgment. Ability to follow prescribed and detailed procedures to solve routine problems.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Routine laboratory physical demands, sitting, standing, stooping and walking, including up and down stairs. May require use of hands and use of arms. Often lifts light-weight material. Rarely lifting/moving average weight (25 to 50 lbs./11-27 kgs) material. Good olfactory and visual capabilities with or without aid. May be required to stand; walk; stoop; bend; kneel; and climb steps.
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Regular exposure to chemicals, solvents, fumes and/or gases.
Be able to work in a laboratory environment which includes hazardous and toxic chemicals; PPE (personal protective equipment) as needed. Care is required to prevent injury to self and others.
