QA Release Technician - 2nd

Role Summary

QA Release Technician I supports GMP-compliant release of materials and finished products. They sample raw materials, assign tests in the LIMS, and coordinate disposition prior to release for manufacturing use, ensuring batches meet specifications and managing holds or investigations. They log batch records, respond to production questions about batch documentation, and work on the 2nd shift (Monday–Friday, 12:00 p.m.–8:00 p.m.).

• 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 SOPs, finished product meets specifications before releasing it to the market, and provides 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.

• 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.

• 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.
• Environmental:
  Occasionally – exposure to loud noises/machinery and exposure to chemicals;
  Rarely – enter confined spaces.
• Other qualities:
  Constant – see (vision);
  Consistently/Frequently – hear, ability to read and write, ability to interpret information, basic math skills, reading and writing in English;
  Occasionally – ability to see colors correctly, hear, intermediate math skills and problem solving for method troubleshooting.