QA Release Technician I

Description Overview

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

Scope of the Role

•    Samples raw materials and assigns tests in LIMS according to approved SOPs, WIs and specifications.  Coordinates disposition of the raw material prior to release for manufacturing use. 
•    Ensures that batches are manufactured according to approved SOP’s, finished product meets specifications before releasing it to the market, and appropriate resolution to batches pending approval due to GMP errors or investigations.
•    Confirms batch, creates batch file, and logs the batch record and any required samples, and manages batch records that are on an investigational, at risk, or hold status.
•    Answers production questions and concerns regarding batch records.

Experience Required

• High School Diploma or GED, with a minimum of two years’ experience working in an FDA regulated industry. 


• Excellent oral and written communication skills, and strong interpersonal skills.

• Thorough understanding of equipment operation and manufacturing processes.


• Demonstrated strong analytical skills, and ability to work independently against multiple deadlines.


• Thorough knowledge of SOPs, and be able to provide clear direction and interpretation to staff in multiple areas.


• Demonstrated understanding of and ability to apply cGMPs, and ability to recognize variances from cGMPs. 

Essential Functions of Job

Physical requirements: 

Consistently/Frequently – Stand, walk, Lifting up to 50 lbs., feel with hands/fingers, reach, grasp, move items/boxes

Occasionally – Sit, lifting above shoulders and head less than 50 lbs., pull, push, climb ladders, climb stairs, stoop/bend, squat, kneeling, reach above shoulders and head,.

Rarely - Twisting