Assoc QC Reviewer

Athlone, Ireland
13 Sep 2019
08 Oct 2019
Quality, QA / QC
Full Time
Contract Type
Experience Level
Experienced (non-manager)
The basic purpose of the dedicated Analytical Reviewer role is to assure the quality of laboratory data and reports. This is accomplished by reviewing chromatographic data and related notebooks as specified by Standard Operating Procedures. The objective of the data review process is to evaluate chromatographic data to assure compliance with analytical methods, FDA's Good Laboratory Practices and/or Good Manufacturing Practices and client criteria.


Education and Experience:
  • BS in science or a related field.
  • 1-2 years of QA/QC experience is required as well as a thorough knowledge of Federal regulations and SOP's.

Knowledge, Skills and Abilities:
  • Knowledge of chromatography, divisional SOPs and FDA regulations.
  • One year of QC experience; lab experience preferred.
  • Good verbal and written communication skills.
  • Must be detail oriented and able to deal with multiple and changing priorities.

Working conditions
  • Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
  • Occasional drives to site locations, occasional domestic travel.
  • 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.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.