SPECIALIST QUALITY

The QC  Specialist (Chemist) is responsible for prioritizing daily sample testing and performing a variety of laboratory tests on raw materials, in-process samples, and finished products.  This role reviews compounding and laboratory records for accuracy and completeness, investigates customer complaints, and handles out of spec (OOS) or out of trend (OOT) results including implementing any corrective action as directed by QC leadership.   

FUNCTIONS OF THE JOB: 

1. Behavior: Exhibit team player qualities of cooperation, coordination, and professional interaction in all business contacts. 

1. Attendance/Punctuality: Presence at work on time when scheduled is a mandatory function.  

1. Safety: Compliance with all company safety rules, procedures, and guidelines is mandatory. 

1. Perform laboratory analysis on incoming raw materials, in-process samples, and finished products per established procedures, including wet chemistry, GC & HPLC. 

1. Prepare samples for chromatographic analysis. 

1. Maintain a clean, safe, and organized laboratory environment at all times.    

1. Coordinate information flow within the laboratory and to internal customers.   

1. Access, input, and retrieve information from the QC computer systems. 

1. Approve or reject raw materials, process samples, and finished products for release or sale. 

1. Be thoroughly versed in GMP regulations and ensure that all laboratory documentation meets standards for completeness and accuracy.  

1. Demonstrate a complete understanding of safe procedures for handling, processing, and storing hazardous and/or flammable products and raw materials in compliance with local, state, and federal guidelines.   

1. Document and report deviations in performance not anticipated or indicated in test procedures. 

1. Maintain a thorough understanding of QC procedures, manufacturing processes, workflow, the QC retain program, and documentation procedures. 

1. Work with minimal supervision while effectively re-prioritizing work schedules to meet production demands.   

1. Be proficient in performing routine GC and HPLC analysis in an efficient and accurate manner. 

1. Perform all assigned laboratory tasks accurately, efficiently, and within established timelines.     

1. Provide timely, accurate information to production personnel. 

1. Participate in department meetings as required. 

1. Complete all assigned training assignments within established deadlines. 

1. Perform other related duties as assigned by QC leadership. 
   
    

   Work Environment: 

   This position operates in a laboratory environment with routine use of office equipment, including computers and photocopiers.  Must follow company safety protocols and wear appropriate PPE. 

   Physical Demands: 

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

Physical Activities: Walking, talking, hearing, climbing, balancing, reaching, grasping, standing, and stooping.  

Physical Demands: Occasionally lift boxes of up to 40 lb; frequently handle smaller samples (1-5 lb). 

Visual Acuity: Clarity of vision at 20 inches or less, distinguish colors, and adjust focus for laboratory analyses.   

Environmental/Atmospheric Conditions: Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort.  Exposed to sufficient noise to cause worker to shout to be heard above the ambient noise level.  Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.  PPE must be used at all times. 

Education Requirements: 

Required:   

• Bachelor’s degree (BS/BA) degree in Chemistry or related science.  

• Must have a thorough understanding of FDA regulations and strong working knowledge of laboratory testing procedures.  

• Must demonstrate the ability to use laboratory equipment safely and efficiently.    

Experience Requirements: 

Required: 

• 1-2 years of progressive Quality Control experience in a laboratory environment. 

• Must be proficient in analytical testing techniques and demonstrate strong attention to detail. 

• Must have interpersonal skills and the ability to work well independently while making sound decisions under pressure.    

Competencies: 

• Laboratory Instrumentaiton: HPLC, GC, FT-IR, TOC analyzer, viscometer, densitomer, pH meters and balances. 

• Software and systems: QC computer system, LIMS and Microsoft Office Suite. 

• Standard laboratory glassware, chemical reagents, and safety procedures. 

Certificates, Licenses, Registrations: Not required