QC Auditor / Reviewer - Empower - GMP

Education and Experience:

• Bachelor's degree in life or physical sciences with a preference in Chemistry, Analytical Chemistry, or Pharmaceutical Chemistry or equivalent and relevant formal academic / vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience. 

Knowledge, Skills and Abilities:

• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP

• Thorough knowledge of chromatography and divisional SOPs

• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards

• Strong verbal and written communication skills

• Strong attention to detail

• Ability to independently review laboratory reports and analytical methods

• Ability to deal with multiple and changing priorities

• Ability to provide clear and concise feedback and/or documentation of results

• Ability to work in a collaborative team environment

• Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use

• Knowledge of HPLC, GC, KF, TOC, and dissolution

• Ability to utilize Microsoft Excel and Word to perform tasks

• Time management and project management skills

• Problem solving and troubleshooting abilities

Working Conditions:

• Work is performed in an office environment with exposure to electrical office equipment. 
  

• May have exposure to laboratory and/or a clinical environment 
  

• Exposure to biological fluids with potential exposure to infectious organisms.

• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.

• Personal protective equipment required such as protective eyewear, garments and gloves.

• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements

• Ability to work in an upright and /or stationary position for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.

• Occasional mobility needed.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others to obtain or relate information to diverse groups.

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance.