POSITION PURPOSE
A brief summary of the purpose this position must fulfill.

Provide Quality Control laboratory service to fulfill pharmaceutical and medical device requirements pertaining to products manufactured by or for Kavis Pharma LLC.These services assure the quality of products through testing, calibration and validation.

ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

2. Perform analytical method validation/transfer and assess in advance the required specifications and method, equipment and materials to support the method validation activities.

3. Provide input for method development of analytical method. Provide technical support on HPLC and GC trouble shooting. Act as a scientific resource for the company.

4. Provide support on lab investigations (OOS, OOT and OOP) and evaluate corrective/preventative actions (CAPA) to assure it addresses the identified cause of the event. 

5. Schedule and coordinate method validation/transfer activities with donor sites and clients.

6. Prepare lab related control documents to include Test Methods (TM), Raw Materials Acceptance (RMA), Bulk and Finished Product Specifications (SPC), Product Stability Specifications (STA), Calibration Test Methods (CTM), Technical Support (TS), Protocols and Reports, Method Transfer/Validation documents and company's memo.

7. Write technical analytical reports and procedures

8. Provide support for training of new chemists or analyst.

9. Implement special projects as assigned and provide technical support to production.

10. Perform testing of raw materials, in-process product, finished product, and stability of products through wet chemistry and instrumental analysis per ICH guidelines, USP, EP and compendial monographs. Ensure proper handling of hazardous materials and hazardous waste generated while performing QC activities.

11. Perform other duties as assigned.

QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE
Must possess working knowledge of laboratory instrumentation. Knowledge in ICH guidelines, USP, EP and FDA regulations. Extensive hands on experience in HPLC (high performance liquid chromatography) and GC (gas chromatography), chromatograph and trouble shooting. Must possess the ability to critically evaluate and audit data. Project management and method development exposure are a plus.

SKILLS AND ABILITIES
Must possess excellent written and verbal communication skills, interpersonal skills, management skills, strong work ethic, consensus gathering skills, organizational skills and a working knowledge of Empower Systems, Laboratory Information Systems (LIMS), Microsoft Office including Word, Excel and Outlook. Provide solutions to a variety of technical problems to moderate scope and complexity.

SUPERVISION
Position functions autonomously.

EDUCATION/ EXPERIENCE
Minimum of a Bachelor or Master of Science Degree required. Minimum of 5 year (s) experience in the pharmaceutical industry. However, a combination of experience and/or education will be taken into consideration.

LICENSES/CERTIFICATIONS
None required 

LANGUAGE SKILLS
Ability to read and write using the English language. Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.

MATHEMATICAL SKILLS
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.
 
REASONING ABILITY
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

Routine laboratory physical demands, sitting, standing, stooping, walking including up and down the stairs and lifting (under 25 lbs, unassisted). Good olfactory and visual capabilities with or without aid. Periodic travel is required. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Light lifting requirements.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. 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.