Packaging QA Associate

Description

The role supports distribution services in the US, run through the AmerisourceBergen business within the company.

The shift runs Monday to Friday, 3:00pm to 11:30pm.

Responsibilities

• Guide daily QA and production work, along with other tasks that may come up.
• Check production batch records at each packaging step for accuracy and compliance, and complete the final check before they go to Product Release.
• Handle serialization work, such as sending print jobs and releasing, suspending or cloning work orders to keep production moving.
• Find and correct discrepancies in non-controlled product and packaging component records in the relevant systems.
• Make sure any deviations and their supporting paperwork are attached to the batch record.
• Carry out in-process quality checks as needed.
• Run specific gravity tests and TOC analysis.
• Swab for cleaning validation when the Stability department asks.
• Write and update work instructions and SOPs for your daily tasks.
• Raise non-conformances from production with management, lead root cause analysis of quality incidents, join investigation discussions, and draft Unplanned Deviations for management review.
• Complete required technical, compliance and quality team training. Work with Sampling, Label and Documentation, Production and Warehouse to fix issues and improve processes, including efficiency work that gets team members more involved on the production floor.
• Serve on the site internal audit team for QA Production. Follow cGMP, safety rules and SOPs.

Requirements

• Have a high school diploma or GED.
• Read and understand English well enough to work from documents, product labels and instructions.
• Write clearly and accurately enough to complete compliance records for production runs.
• Know your production area well enough to troubleshoot problems as they come up.
• Have basic math skills.
• Build and maintain good working relationships with colleagues.
• Stay organized and pay close attention to detail.
• Use sound judgement to follow detailed instructions.
• Work independently and juggle several tasks at once.
• Communicate well verbally and in writing.
• Be comfortable with ERP systems, Microsoft Office (Outlook, Word, Excel) and computer-based training.
• Be able to reach, bend, kneel, stoop, lift, grasp, handle repetitive motions, and talk and hear clearly.
• Lift up to 50 lbs with assistance.
• Have close, distance and peripheral vision, and be able to adjust focus.
• Stand and walk for most of the shift, and stay calm under stressful situations.

Conditions

This is a full-time position.

The equal opportunity statement is omitted.

Benefits

• Medical, dental and vision coverage.
• Wellness support across physical, emotional, financial and social areas, including backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave and paid caregiver leave.
• Training programs, professional development, mentorship, employee resource groups and volunteer activities.