Benefits:

401(k)

401(k) matching

Dental insurance

Health insurance

Paid time off

Vision insurance

The Senior Chemist performs testing of samples in the product fulfillment process according to FDA and other applicable regulatory standards, participates in investigations related to QC processes or data, trains QC employees, troubles shoot methods and processes, performs testing of samples, maintains and troubleshoots testing equipment. Serves as the primary link between the QC team and the QA facilitator, for day-today activities, such as schedules and workload planning, coordinates workflow in QC team, verifies QC data, while monitoring for trends and abnormalities. Performs project work, and leads laboratory investigations, develops methods and processes.

DUTIES & RESPONSIBILITIES:

The following responsibilities would characterize the requirements of this position. Must possess the skills necessary to perform the majority of the listed functions:

1. Review and approve the documentation setting forth the basis for qualification of any supplier.

2. Performs project work, and participates in investigations

3. Trains QC employees in GMP, QC methods and processes

4. Troubleshoots methods and processes

5. Serves as an expert in a specific area of laboratory equipment, process or system

6. Enter and review data and other analytical equipment as appropriate

7. May serve as the primary link between QC team and QA Facilitator

8. Complete final review and approval of product specifications, production batch records, laboratory raw data, labels, and COAs for raw materials and finished products

9. Send laboratory releases to customers

10. Monitor and track instrument calibrations and preventative maintenance

11. Coordinates workflow in QC team, directs priorities and testing schedules

12. Verifies and approves QC data, while monitoring for trends and abnormalities. Reports, and acts on data results

13. Serves as QC lead for investigations in process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling and testing

14. Assist the Director of Quality to complete internal Lab audits to ensure policies and regulations of FDA (cGMP), TDA, third party certifiers and internal SOPs are followed

15. Develops and validates new Lab methods

16. Serves as primary contact for contract services, including laboratory testing

17. Serves as the technical leader in the laboratory

18. Serves as the main contact for issues as they arise, and aid/direct troubleshooting activities when appropriate

19. Main point of contact for finished product testing

20. Main point of contact for raw material program

21. Acts as a leader in the laboratory through display of leadership capabilities

22. Aid in the development of chemists through mentoring and training.

REQUIREMENTS:

Competencies

1. Master’s degree in Chemistry, Chemical Engineering, Biochemistry, Biomedical or related field is required

2. A Ph.D. or post-doctoral experience is strongly preferred

3. Hands-on experience must with Inductively Coupled Plasma Mass Spectroscopy (ICPMS). And High-Performance Thin-Layer Chromatography (HPTLC), High-Performance Liquid Chromatography (HPLC) machinery is a plus

4. Strong background in Food Science is highly desirable

5. This wording highlights the educational requirements, technical skills, and specific focus areas needed for the role. Internal and External Contact/Customers

6. Working knowledge of Microsoft office and general computer concepts

7. Ability to demonstrate effective leadership skills

8. Ability to follow GMP and SOP guidelines

9. Good written and verbal communication skills and problem-solving skills

10. Good organizational skills with a strong attention to detail

11. Ability to multi-task and prioritize responsibilities

12. Ability to work both independently and in a team environment