- Job Level:
The Inspector Quality Assurance (2nd shift) is responsible for performing duties related to, but not limited to, in-coming materials (i.e. sampling, review specification, and release materials in SAP and any other related electronic database), line inspections and packaging lines, reviewing batch records when required, and performing all quality assurance activities in accordance with cGMP and standard operating procedures. The Quality Insurance Inspector will be tasked with performing a review of incoming materials, verifying the shipments meet Company requirements, and notifying Management of any discrepancies.
- Perform all sampling of raw materials, packaging components and printed material following SOP, ANSI, CFR, and EHS guidelines.
- Perform review of QC Specification; ensure all test result met specifications requirements and release of incoming materials, packaging components and printed materials in the electronic database.
- Assign retest or expiry dates as per SOP. Apply stickers to identify the materials status.
- Perform QA inspection as per batch record in SDF, packaging lines adhering to all GMP and EHS guidelines.
- Be able to work in a sterile environment. Review packaging and manufacturing batch records, perform calculations and yields. Perform AQL inspection and correctly identify a defect.
- Review and release batches in SAP for shipment. Assist with other QA related tasks as delegated by QA Manager. Completes TrackWise assignments. Other duties as assigned.
- High School Diploma or GED
- Post-secondary education is desirable
Experience & Skills Required
- 1-2 years working experience in QA, warehouse or material handling in a GMP environment, preferred but not required.
- Working knowledge of ANSI sampling plans
- Working computer knowledge; (familiarity in SAP R/3, TrackWise a plus), spreadsheet and database computer programs.
- Communicates and multi-tasks effectively. May be required to wear personal protective equipment
- Accuracy – Ability to perform work accurately and thoroughly
- Time Management – Ability to utilize the available time to organize and complete work within given deadlines.
- Accountability – Ability to accept responsibility and account for his/her actions.
- Detail Oriented – Ability to pay attention to the minute details of a project or task. Persistence –
- Ability to complete tasks or continue in a course of action in spite of opposition or discouragement.