Overview
QA Analyst Jobs in Remote at Grand Software Solutions
Location: Verona, WI
Job Summary and Purpose:
Responsible for assuring the consistent quality of products and services by examining and reporting on the adequacy and/or deficiencies associated with documentation created during manufacturing and testing activities from receipt of inbound materials to final product shipment. This position will also support and assist with the day-to-day administration of the company’s quality systems and document control programs.
Responsibilities and Key Duties:
Review records and data for accuracy and adherence to internal procedures, good manufacturing practices, and regulatory requirements; using a guided processes for direction
Conduct authorized sampling of final products
Schedule and coordinate processing of final product samples for shipment
Maintain inventory of final product retention samples and final product stability samples
Understand and apply the Quality Management System (QMS) procedures and policies
Issue records for process execution
Perform release of inbound materials and in-process materials using the guided process
Record and track data for trending and/or evaluation
Update and maintain tracking log systems
Assist with the administration of quality documents and the document control system
Assist with the organization and maintenance of quality department files
Explain and role model the expected ‘quality behaviors’ on the shopfloor
Core Competencies:
Solutions out of complexity – Work to evolve immediate environment
Client focus – Make sure needs and requests are treated equally and in a positive way
Collaborate with empathy – Fully takes part in the working group to share information, listens to others and have a clear idea of the decisions made
Engage and develop – Open to share knowledge and to receive feedback from others
Drive ambition and accountability – Ensure accuracy of work with the use of KPI’s and a responsible commitment
Influence others – Show confidence while speaking
Technical / Functional Competencies:
Basic knowledge and understanding of Ceva’s organization, products and processes
Basic knowledge of continuous improvement tools and investigation tools with the capability to identify issues
Knowledge of the specific technical standards, guidelines and tools
Capability to analyze issues and propose solutions
Demonstrated understanding of the quality impact on production
Strong analytical skills
Strong sense of teamwork with respect to working with other stakeholders, internal and external
Must be able to become gown certified for entry into aseptic processing laboratories
Thorough attention to detail with respect to documentation, communication and organization
Strong communication skills, both written and verbal
Flexibility to work overtime as needed, or outside of normal business hours, which may include weekends and holidays
Able to work under time constraints and deadlines
Working knowledge of Microsoft Office
Basic data entry skills
Knowledge of quality system tools and how to apply them covering the streams requested by the main global regulations
Qualifications:
Education – Bachelor’s degree in biological science or Quality Management System (QMS), preferred, or Associates degree plus equivalent work experience
Work Experience – Minimum of one year of experience, preferred or demonstrated competency in a regulated biotech, or pharmaceutical industry environment. Experience with record and document auditing, preferred
Physical Requirements:
Ability to read, write legibly and communicate in English
Tasks frequently require prolonged, mental, and visual concentration
Able to sit or stand for long periods of time
Working Conditions:
Office space
Clean room manufacturing laboratory
Travel Required:
N/A
This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.
VEVRAA Federal Contractor
**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.
669B
Your profile :
Education – Bachelor’s degree in biological science or Quality Management System (QMS), preferred, or Associates degree plus equivalent work experience
Work Experience – Minimum of one year of experience, preferred or demonstrated competency in a regulated biotech, or pharmaceutical industry environment. Experience with record and document auditing, preferred
Title: QA Analyst
Company: Grand Software Solutions
Location: Remote
