# Associate Scientist - Deviation & Investigations

**Company:** [SOKOL GxP Services](http://jobs.workable.com/companies/a1S7XpqSYfMsm6jbTL9fWC.md)
**Location:** Summit, United States
**Workplace:** on site
**Employment type:** Contract

[Apply for this job](http://jobs.workable.com/view/92bbbf9d-ccf7-4a9f-9157-d0d144ce4c43)

## Description

**SOKOL GxP Services** is seeking a **junior-level Associate Scientist** to support **deviation investigations and CAPA activities** within a regulated biopharmaceutical environment. This role focuses on **root cause analysis, investigation execution, and technical report writing**, with cross-functional collaboration to ensure timely and compliant resolution of quality events.

### **Responsibilities**

-   Lead and support **deviation investigations**, including Environmental Monitoring (EM) events
-   Perform **root cause analysis** using structured problem-solving tools (e.g., 5 Whys, Fishbone)
-   Author **investigation reports**, including hypothesis development, data analysis, and conclusions
-   Develop, implement, and track **CAPAs** to ensure effective resolution
-   Conduct **GEMBA walks** to support investigations and assess process conditions
-   Collaborate with **Quality, Manufacturing, and Subject Matter Experts (SMEs)**
-   Support **change control activities**, including impact assessments
-   Ensure investigations are completed within required timelines and communicate delays/escalations
-   Participate in **audit and inspection readiness** activities
-   Contribute to **continuous improvement initiatives**

## Requirements

### **Required Qualifications**

-   **1+ year** of experience in a **GxP-regulated environment**
-   Experience with **deviation investigations and/or CAPA processes**
-   Strong **technical writing skills** (investigations, reports)
-   Understanding of **cGMP principles and regulatory expectations**
-   Ability to work cross-functionally in a fast-paced environment
-   Experience with **electronic Quality systems (eQMS)**

### **Preferred Qualifications**

-   Experience in **biopharmaceutical manufacturing**
-   Exposure to **Environmental Monitoring or QC-related investigations**
-   Familiarity with **data trending and basic statistical analysis**
-   Experience supporting **regulatory inspections or audits**

### **Education**

-   Associate’s degree required
-   Bachelor’s degree preferred (Life Sciences, Engineering, or related field)

### **Work Environment**

-   Primarily office-based with some presence in manufacturing areas
-   Potential travel between local sites as needed
-   Flexibility for extended hours or weekends based on business needs

## Benefits

Competitive hourly rate: $37.44 - 47.55/hr **(W-2 only, no C2C)**

Working Hours: Monday - Friday, regular business hours

6-month contract with possible extension

Health insurance, holiday pay, 401(k) program, and other benefits