Quality Assurance Specialist

West Pharmaceutical Services•Cidra, PR

43d•Onsite

About The Position

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 fully onsite role, you will support all quality systems and functions for the respective site. Assists in establishing systems to support the facility to drive continuous improvement and minimize the costs of non-conformance. Plans, schedules, executes, and communicates all items regarding quality issues, complaints, validations, and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards and cGMPs. This role is the interface between the customers and site for supporting audits.

Requirements

Bachelor's Degree or equivalent experience. required
Minimum 3 years Quality department, ideally in a manufacturing environment required
Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
Quality planning and communication skills. Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
Demonstrated problem solving and planning/organizing skills.
Demonstrated proficiency in MS Office products (Project, Word, Outlook, Excel)
Able to communicate effectively with clear, concise, and organized information, both verbally and in writing.
Able to always comply with the company’s safety policy.
Must have strong communication and active listening skills to interact with others in a positive manner.

Nice To Haves

Preferred Knowledge, Skills and Abilities

Responsibilities

Coordinates and supports customer, ISO and corporate quality audits.
Leads and assists in investigation of OOSs, complaints and deviations as necessary to identify and find the root cause of product and related quality issues.
Develops and implements audit plans, schedules and supports internal audits. Prepares customer correspondence and audit responses related to quality audits. Prepares and coordinates audit and compliance related CAPAs.
Supports communication and responses for typical customer questions e.g. during audits, and educates relevant functions accordingly.
Supports all affected functions in bringing their systems and processes into compliance with GMP and DI principles and in maintaining that state.
Participates in creation of Enterprise and local procedures on relevant QA topics and support all affected functions in their implementation.
Assists with process and equipment validations as needed.
Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or comply with corporate or regulatory requirements.
Supports Quality requirements, including: System issues and investigations Assist in assessment and disposition of non-conforming product. Assist in investigations and reporting. Review specification and sampling plans to ensure compliance.
Promotes and supports a Lean environment within the facility.
Performs other duties as required and/or assigned.