Title:  Quality Specialist

Job Summary

In this role as a Quality Assurance Specialist at West Analytical Lab Services, you will be instrumental in providing quality support and ensuring the continuity of cGMP compliance, in line with corporate policies and procedures. Your responsibilities will include ensuring the lab's adherence to regulatory, compendial, ISO, and West requirements while reviewing the quality of work completed by lab personnel. You will be tasked with analyzing data, recommending changes, and verifying their effectiveness, alongside reviewing and approving investigations, corrective actions, validation documents, and relevant change control documentation. By leveraging your knowledge and experience, you will drive initiatives to enhance system effectiveness and efficiency, ensure timely completion of assignments, and support the development and review of lab procedures and work instructions. Additionally, you will play a key role in resolving quality issues, maintaining consistent application of quality requirements, and contributing to the technical writing and editing of procedures and documentation.

Essential Duties and Responsibilities

• Provides QA support to Analytical Lab ensuring compliance to regulatory/compendial, ISO and West requirements.
• Reviews the quality of work completed by the Lab personnel to ensure it meets regulatory/compendial requirements, ISO, West procedures, and customer requirements.
• Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness.
• Reviews and approves the investigations, corrective actions, validation documents and reports, and change control documentation related to Exton Lab.
• As appropriate, use knowledge and experience to take initiatives to improve the effectiveness and/or efficiency of systems.
• Ensures that assignments are completed on time, and at the required level, etc.
• Provides support for the development of procedures and work instructions for the lab including technical editing and writing.
• Participates in the review of lab procedures and work instructions.
• Resolves issues within Quality to ensure consistent application of quality requirements.
• Participates in internal quality audits and customer audits.
• Reviews and provides approval of materials from external warehouses.
• Provides client’s supplier qualification questionnaire response.
• Prepares data and information to be discussed during Management Review and ensure that this review is performed per procedure.
• Supports corporate harmonization initiatives as they pertain to the lab management system.
• Works independently with minimal supervision.
• Performs other duties as assigned based on business needs.

Additional Responsibilities

• Strong communication and technical writing skills, interpretation of data, and interpersonal skills.
• Read and interpret data, information, and documents
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze, and solve problems.

Education

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

Work Experience

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

Preferred Knowledge, Skills and Abilities

• Ability to work independently, multi-task and thrive in fast-paced environment
• Experience with managing Document Control activities within a regulated industry
• Familiarity with Master Control, SAP/ERP system and SharePoint
• Excellent written and verbal communication skills
• Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Able to be aware of all relevant SOPs per Company policy as they are related to the position covered by this Job Description.
• Must have effective problem solving and interpersonal skills
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to always comply with the company’s safety policy.
• Able to always comply with the company’s quality policy.

Travel Requirements

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
• Must maintain the ability to work well with others in a variety of situations
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
• Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
• Effectively communicate and interface with various levels internally and with customers #LI-AP1 #LI-HYBRID