QA Specialist at Abbott Pediatrics

Taguig, Metro Manila, Philippines -

Full Time

Start Date

Immediate

Expiry Date

11 Mar, 26

Salary

0.0

Posted On

11 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Compliance, Problem Solving, Critical Thinking, Data Analysis, ISO Standards, FDA Regulations, Technical Service, Standard Operating Procedures, Customer Complaint Investigation, Communication Skills, Team Collaboration, Database Software, Spreadsheet Software, Word Processing Software, Life Sciences

Industry

Hospitals and Health Care

Description

JOB DESCRIPTION: Abbott Rapid Diagnostics (ARDx) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. This position is located in Manila and may support products within the Abbott Rapid Diagnostics business. In this role you will be responsible for managing and maintaining regulatory compliance programs, as well as providing support as needed to other quality assurance functions. This position is expected to provide problem solving skills and critical thinking for investigation and troubleshooting activities. Essential Duties and Responsibilities Carries out duties in compliance with established business policies and procedures. Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job. Perform other duties and projects as assigned. Perform customer complaint investigation activities, including deciding which complaints will be investigated, how they will be investigated, coordinating data generating activities, evaluating data and writing investigation summaries /conclusions. Maintain effective communication with Intake Hubs (worldwide locations) regarding product complaint investigations. Review of complaint cases at earliest stage to assess Technical Service performance. May perform site visits as needed to assess kit performance, including specific activities for Amplicon remediation. Support revision of Standard Operating Procedures, guidance documents, and training materials as needed. Basic Qualifications – Education / Experience / Skills Bachelor’s Degree in Biology, Chemistry, or Life Sciences, and / or other related technical field or the equivalent education and experience. Proficiency in database software, internet-based software and word processing software. Proficiency in spreadsheet software Proficiency in database software, internet-based software and word processing software. Preferred Qualifications 5+ years of experience in Quality Assurance role in the medical device industry 2+ years of experience in QA/QC role in medical device or biotech industry Competencies Working knowledge and experience with FDA cGMPs/QSR, and ISO Quality system requirements. Demonstrated ability to manage complex programs, and multiple priorities in a timely manner. Demonstrated ability to analyze data and make appropriate conclusions. Ability to work well in dynamic work environment with changing priorities. Ability to work independently and collaboratively. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Facilities & Maintenance DIVISION: ID Infectious Disease LOCATION: Philippines > Taguig City : Five/Neo Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter

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Responsibilities

The QA Specialist will manage and maintain regulatory compliance programs and support quality assurance functions. Responsibilities include customer complaint investigations, maintaining communication with Intake Hubs, and revising Standard Operating Procedures.