Quality Assurance Specialist

Thornton Tomasetti; Taguig; On-site; PHP 600,000 - 900,000; Full time

Job summary

Abbott is seeking a Quality Assurance Specialist in the CMI ARDx Cardiometabolic and Informatics division in Taguig, Philippines. You will support site QA activities, work on document control, training, complaints, CAPA, supplier control, and regulatory compliance.

The role requires a BS/BA in a scientific field, 2 years QA/regulatory experience in manufacturing (preferably in vitro diagnostics), and 4 years in relevant subsystems. Strong writing and MS Office skills are essential.

Qualifications

• 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 power point.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Participate in Quality System processes including training, 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 (e.g. 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.

Skills

Written & verbal communication

MS Office (Excel & PowerPoint)

Education

BS/BA in chemistry, biology, or related field

Tools

MS Office Suite

Job description

JOB DESCRIPTION: Abbott Rapid Diagnostics 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. The position of Quality Assurance Specialist is within our CMI Business Unit. This role 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 job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES

• 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.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE

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 power point.

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.

COMPETENCIES

Drives for results Attention to detail Initiative Communication Adaptability

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: 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.

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