Quality Assurance Specialist – Abbott Laboratories – Westbrook, ME

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries

QUALITY ASSURANCE SPECIALIST

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health. Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

WHAT YOU’LL DO

We are recruiting for a QUALITY ASSURANCE SPECIALIST to join our team within our Infectious Disease Developed Markets (IDDM) business unit located in Westbrook, ME. In this role you will perform a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting records and documentation reviews of manufacturing and Quality Control records and audits of production operations. You may also administer the calibration program, the sample retention program, the Document Control and the Quality Records program, and/or assist and act as backup to the Document Control administrator.

• Reviews production batch records (DHR’s) for accuracy and completeness in order to approve intermediate products for use in production. Reviews finished goods batch records. Reports all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
• Conducts spot-check inspections/audits of production operations
• Participates in the internal audit program
• Writes, reviews and approves Standard Operating Procedures (SOPs) as necessary
• Assists with and may write validations/test protocols as necessary
• May assist in testing of complaint samples and stability samples and reports results out of acceptance limits
• Provides backup to other Quality Specialists
• May administer the calibration program.
• May administer the Document Control program
• May administer the Deviation Reporting program and coordinate the MRB process.
• May administer the Quality Records program and assist and act as backup to the Document Control Specialist

EDUCATION AND EXPERIENCE REQUIRED

• Bachelor’s Degree in Biology, Chemistry, Life Sciences, or another related technical field
• 1+ years of experience performing similar compliance responsibilities in a Quality Assurance department within a FDA controlled environment, including performing batch record reviews
• Demonstrated ability to understand and adhere to quality documentation and excellent writing skills – must be able to summarize complex issues in a clear, succinct, and accurate manner and be able to write in a manner that effectively conveys complex issues to the reader
• Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
• Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization
• Proficient in MS Office (Word, Excel, PowerPoint, Outlook)

PREFERRED

• Advanced level degree in Biology, Chemistry, Life Sciences, or another related technical field
• Medical device experience
• Knowledge of the QSR or ISO 13485
• Ability to find root cause of why an issue occurred and review action plans and determine if the actions taken effectively address the issue

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

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  Training and career development, with onboarding programs for new employees and tuition assistance
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  Financial security through competitive compensation, incentives and retirement plans
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  Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

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  Paid time off
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  401(k) retirement savings with a generous company match
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  The stability of a company with a record of strong financial performance and history of being actively involved in local communities