Quality Specialist

West Pharmaceutical Services•Uwchlan Township, PA

7d•Hybrid

About The 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. At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Job SummaryIn 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.

Requirements

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

Nice To Haves

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.

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.