Quality Specialist

Hybrid Position

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation is provided for this opportunity.

West is a dedicated team focused on improving patient lives, rooted in a century of expertise in delivering life‑saving injectable medicines.

As a Quality Assurance Specialist at West Analytical Lab Services, you will provide quality support and ensure the continuity of cGMP compliance, aligning with corporate policies and procedures. Your responsibilities include reviewing lab personnel work against regulatory, compendial, ISO, and West requirements; analyzing data and recommending changes; approving investigations, corrective actions, validation documents, and change control documentation; driving initiatives to enhance system effectiveness and efficiency;

and supporting the development and review of lab procedures and documentation.

• Provide QA support to the Analytical Lab ensuring compliance with regulatory, compendial, ISO, and West requirements.
• Review the quality of work completed by lab personnel to ensure it meets regulatory, ISO, West procedures, and customer requirements.
• Review data, analyze results, recommend changes based upon findings, and verify effectiveness.
• Approve investigations, corrective actions, validation documents, reports, and change control documentation related to the lab.
• Use knowledge and experience to take initiatives to improve the effectiveness and/or efficiency of systems.
• Ensure assignments are completed on time and at the required level.
• Support development of procedures and work instructions, including technical editing and writing.
• Participate in the review of lab procedures and work instructions.
• Resolve quality issues to ensure consistent application of quality requirements.
• Participate in internal quality audits and customer audits.
• Review and approve materials from external warehouses.
• Respond to client supplier qualification questionnaires.
• Prepare data and information for Management Review, ensuring the review follows procedure.
• Support corporate harmonization initiatives related to the lab management system.
• Work independently with minimal supervision.
• Perform other duties as assigned based on business needs.

• Strong communication and technical writing skills; interpretation of data and interpersonal skills.
• Read and interpret data, information, and documents.
• Work well with others in a variety of situations.
• Multi‑task, work under time constraints, problem‑solve, and prioritize.
• Make independent and sound judgments.
• Observe, interpret situations, analyze, and solve problems.

• Bachelor's degree in a scientific discipline preferred; applicable work background and experience may be considered as a substitute.

• 3+ years of experience in regulated Quality Assurance / Quality Control.
• 3+ years of experience in medical devices or the pharmacy industry preferred.
• Knowledge of cGMP regulations, ISO standards, and broader regulatory frameworks.

• Work independently, multi‑task, and thrive in a fast‑paced environment.
• Experience managing Document Control activities within a regulated industry.
• Familiarity with Master Control, SAP/ERP, and SharePoint.
• Excellent written and verbal communication skills.
• Proficient in Windows OS and Microsoft Office Suite (Word, Excel, PowerPoint).
• Awareness of all relevant SOPs per company policy related to this position.
• Effective problem‑solving and interpersonal skills.
• Contribute to Lean Sigma programs and activities toward delivery of set targets.
• Compliance with the company’s safety and quality policies.

None:
No travel required.

Sedentary – exerting up to 10 lbs (4 kg) of force occasionally, and/or negligible force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

• Adaptable to changes in the work environment, manage competing demands, and deal with frequent changes, delays, or unexpected events.
• Maintai…