Quality Assurance Specialist - Global Business Services

Job description

JOB DESCRIPTION:

Point-of-care diagnostics is a growing and dynamic industry helping to improve clinical and economic outcomes globally. Abbott brings a variety of expert viewpoints on new innovations, insights, and impacts that are shaping the future of diagnostics around the world.

Abbott Rapid Diagnostics Manila, Philippines site is part of Global Business Services (GBS) within the Abbott Rapid Diagnostics (ARDx) Division. GBS has a global accountability to deliver an exceptional customer experience and create business value through compliance, standardization and data analytics. GBS also designs and develops Software products for ARDx businesses. The GBS group fosters a collaborative, team focused and winning environment where employees are accountable and encouraged to develop themselves. 

The Quality Assurance Specialist (QA) is responsible for supporting the management review, document and records control, and continuous improvement programs.

Key Responsibilities:

· 
Comply with Quality System SOPs and Work Instructions and suggest modifications to ensure on-going process compliance and efficiencies

· 
Conduct quality control/audit activities for select quality documents and records, complete results trending and present findings to drive continuous improvements

· 
Support the Document and Records Control program

· 
Maintenance of Training Records

· 
Maintenance of External Records

· 
Maintenance of Document Master Data

· 
Generate and Distribute Metric Reports

· 
Assign Document Training in Electronic Training System (METRO)

· 
Serve as Change and Quality Coordinator in Agile PLM

· 
Serve as System Administrator for Agile PLM and METRO

· 
Assist in the Management Review process through metric report generation and power-point presentation preparation

· 
Support internal and external compliance audits (i.e. FDA, ISO)

· 
Provide back-up support for the management of the Quality Mailbox and UDI activities

· 
Other duties as assigned

Qualifications:
Education

· 
Minimum Bachelor’s Degree in a technical or life science field, or an equivalent combination of education and work experience is required.

Skills & Experience

· 
Minimum one-year experience in a quality/compliance function required

· 
Basic knowledge of FDA and ISO regulations applicable to medical device industry preferred

· 
Must have strong organizational, interpersonal, written and verbal communication skills with a strong attention to detail

· 
Must be self-directed, adept at juggling multiple projects and comfortable in a fast-paced and ever-changing work environment

· 
Must be proficient in MS Outlook, MS Word, and MS Excel

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:

IDEM ARDx Infectious Disease Emerging Markets

        

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)