Finding the best job has never been easier
West Pharma Quality Auditor United States, Puerto Rico 531894980
07.02.2025
Share
Job Summary
In this 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.
Essential Duties and 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.
Education
- Bachelor's Degree or equivalent experience. required
Work Experience
- Minimum 3 years Quality department, ideally in a manufacturing environment required
Preferred Knowledge, Skills and Abilities
- 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.
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of 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.
Additional Requirements
- Must have strong communication and active listening skills to interact with others in a positive manner.
These jobs might be a good fit
