Lab Technician

4 weeks ago

Newtown, United States KVK Tech Full time
Job DescriptionJob Description

Department

Quality Control

Job Title

Lab Technician

FLSA Status

Non-Exempt

 

1. Role Purpose:

Primary responsibility is to complete documentation and analytical testing of raw materials, in-process materials, stability samples, finished products and product development in a timely manner, while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.

 

2. Key Duties & Responsibilities:

  • Follow cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), 21CFR211.22, 21CFR211.28 and 21CFR211.170.
  • Follow the OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency) safety regulations.
  • Follow all DEA (Drug Enforcement Agency) regulations per laboratory SOPs.
  • Keep Chemicals organized and in proper storage areas.
  • Receive Chemicals and Laboratory materials and keep log.
  • Perform analytical testing of raw materials, in-process materials, stability samples, finished products and product development products using different analytical techniques in compliance with written, approved methods.
  • Document all performed analysis as per cGMP, USFDA and 21CFR211.194 guidelines. Maintain laboratory records including notebooks, logs, and other pertinent documentation in compliance with cGMP, SOPs, and good laboratory documentation guidelines.
  • Ensure all instruments are qualified, and calibrated before each use.
  • Ensure all instruments are maintained, cleaned and used appropriately.
  • Place chemical and solvent orders
  • Follow all SOPs.
  • Comply with FDA guidelines/Company Policies of Data Integrity
  • Other duties as assigned or delegated

 

3. Typical Supervisory Responsibility:

N/A

 

4. Education & Experience:

BS Chemistry or related science field preferred

 

Experience Requirement

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

  • Working knowledge of HPLC, UPLC, GC Dissolution, AA, or UV spectrophotometers preferred
  • Good verbal and written English

 

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A

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