Abbott · 16 hours ago
Quality Assurance Specialist I
Pomona, CA
Full-time
Onsite
New Grad, Entry Level
$74K/yr - $116K/yr
0+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The position of Quality Assurance Specialist I will support site QA activities and primarily focus on key quality subsystems, including document control, training, and regulatory compliance.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
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
Qualification
Required
BS/BA degree in chemistry, biology, or other scientific discipline or equivalent combination of education and work experience
0-2 years' experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics
0-4 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
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
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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