Quality Assurance Associate

Aurora Pharmaceutical LLC

 

Job title: Quality Assurance Associate

Supervisor: QA Manager

Overview: Obtains samples of raw materials, work in process, finished products, stability products, water and environmental factors. Records data. Maintains electronic and paper archives. Supports QA activities

 

Duties:

  • Maintains and organizes QA document control system*
  • Issues, maintains and organizes training databases*
  • Reviews and archives batch records, cleaning records and daily/monthly logs*
  • Issues batch and cleaning records*
  • Samples raw materials*
  • Tracks and documents reserve samples*
  • Performs deliverable volume testing*
  • Performs line clearances*
  • Performs finished product QA inspections*
  • Samples packaging material, in process and finished products*
  • Maps and records stability chambers data*
  • Logs, delivers and pulls retains*
  • Maintains inventory of stability samples*
  • Maintains calibration logs along with all other QA logs*
  • Labels stability samples*
  • Supports QA and Regulatory Affairs for submissions and audits*
  • Reviews packaging labels*
  • Accurately maintains laboratory data and logs*
  • Accurately interprets and reports results*
  • Collaborates in cross-functional teams*
  • Follows all Aurora Pharmaceutical policies, procedures, SOPs, regulations and the employee handbook.*
  • Follows designated work schedule.*
  • Meets deadlines*
  • Assumes additional responsibilities as requested.*
  • Accepts and acts upon supervisory directions
  • Demonstrates flexibility, i.e. willingly takes on new tasks.*
  • Meets the following physical requirements:*

Sits, stands, walks 80% of the time*

Less than 20% of the time, lifts containers or pushes a cart with 30-100 lbs*

(*denotes essential job functions)

 

Knowledge, Skills & Abilities:

  • Strong organizational skills
  • Strong word and excel skills

 

Education and Experience:

  • Bachelor’s degree in biology, chemistry, or biological sciences
  • And 3 years’ experience in a Quality Role
  • Degree in microbiology or biochemistry preferred

 

This job description is subject to change at the sole discretion of Aurora Pharmaceutical.