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*
- 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 data*
- Logs, delivers and pulls retains*
- Maintains inventory of stability samples*
- 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 or associates degree in biology, animal science, or biological sciences
- Or 3 years’ experience in a technical role
- Degree in microbiology or biochemistry preferred
This job description is subject to change at the sole discretion of Aurora Pharmaceutical.
