Associate-QA - Quality Operations

Description

The role supports a business unit of the company that provides pharmaceutical packaging services in the US.

The shift runs Sunday to Thursday, 11:00pm to 7:30am.

Responsibilities

• Lead and guide daily QA and production work. The list of tasks may extend beyond what is written here.
• Review production batch records during packaging for accuracy and compliance, and complete the final check before the batch goes to Product Release.
• Send print jobs, release, suspend, and clone work orders in the serialization process to keep production moving.
• Find and fix discrepancies between non-controlled product and packaging components in the systems.
• Make sure deviations and their supporting documents are attached to the batch record.
• Run quality in-process checks when needed.
• Carry out Specific Gravity testing and TOC analysis.
• Swab for cleaning validation when the Stability department asks.
• Write, review, and update work instructions and SOPs used in daily work.
• Raise non-conformances from production with management, lead root cause analysis for quality incidents, join investigation discussions, and draft Unplanned Deviations for management review.
• Complete technical, compliance, and other required training for the quality team.
• Work with Sampling, Label and Documentation, Production, and Warehouse to solve problems and improve processes through continuous improvement work that boosts efficiency and team involvement on the production floor.
• Serve on the site internal audit team as the QA Production representative. Follow cGMP, safety rules, and SOPs. Perform other assigned duties.

Requirements

• You need a high school diploma or GED.
• Read and understand English well enough to work from documents, product labels, and instructions.
• Write clearly enough to complete compliance records for production runs accurately.
• Know the process in depth and solve basic problems that come up during production.
• Do basic math.
• Build and keep cooperative working relationships.
• Stay organized and pay close attention to detail.
• Use sound judgment to carry out detailed instructions.
• Work independently and juggle several tasks at once.
• Communicate well both verbally and in writing.
• Be comfortable with ERP systems, Microsoft Office (Outlook, Word, Excel), and computer-based training.
• Physically, you reach, bend, kneel, stoop, lift, grasp, feel, and make repetitive motions, with finger dexterity. You talk and hear, and you can lift up to 50 lbs with help.
• You need close, distance, and peripheral vision, and the ability to adjust focus.
• You stand and walk for much of the shift.
• You stay steady under stressful situations as they arise.

Conditions

Full-time position on the Sunday to Thursday, 11:00pm to 7:30am shift.

The warehouse area is generally noisy.

Reasonable accommodations are available for people with disabilities to perform the essential functions of the job.

Benefits

• Medical, dental, and vision coverage.
• Support for physical, emotional, financial, and social wellbeing.
• Family support including backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.
• Training programs and professional development resources.
• Mentorship, employee resource groups, and volunteer activities.