Quality Assurance Specialist

JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

As the Quality Assurance Specialist, you will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, complaints, nonconformances, CAPA and/or supplier control. This role is responsible for implementing and maintaining the effectiveness of the Quality System and supporting regulatory compliance activities.

What You’ll Do

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
• Aid in implementing process improvements with respect to Quality Assurance processes.
• Maintain Quality metrics as required.
• Manage and/or assist with complaints, CAPA, change requests, NCMRs, deviations.
• Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits).
• Assist in determining quality attributes and requirements. May provide technical assistance.
• Utilize quality management techniques to perform investigations and facilitate solutions.
• Work with managers to coordinate training requirements for employees as required.
• Manage training program and organizational chart as required.
• Perform Quality System Training Requirements as needed.
• Review/approve supplier surveys and make recommendations as required.
• Assist with internal audits and agency audits.
• Manage Document Control as required.
• Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors.
• Drives functional performance to ensure that cross-functional standards and expectations are met.
• May assist in the training of personnel as directed by management.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Manage equipment maintenance and calibration program as required.
• Assist with equipment, process and facility qualification and validation activities as required.
• 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.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Perform other duties and projects as assigned.

Requirements

• BS/BA degree in chemistry, biology, or other scientific discipline or equivalent combination of education and work experience.
• 2 years’ experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics.
• 4 years of relevant work experience in assigned subsystem(s).
• Writing and Communication Skills (e.g. write technical reports, present data analysis).
• Experience with MS Office including Excel and PowerPoint.
• Must be detail-orientated, self-motivated and available for flexible scheduling.

Preferred Qualifications

• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR.
• Demonstrated initiative and problem-solving skills.
• Ability or aptitude to use various types of databases and other computer software.
• Strong organizational skills.
• Ability to clearly, concisely and accurately convey communications.
• Knowledge of quality management techniques and application.
• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.

Key Competencies

• Drives for results
• Attention to detail
• Initiative
• Communication
• Adaptability

Location

This position is based in Philippines.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

CMI ARDx Cardiometabolic and Informatics

LOCATION:

Philippines > Taguig City : Five/Neo Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable