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Immucor, Inc. Post Market Surveillance Specialist in Norcross, Georgia

Overview

Founded in 1982 and based in Norcross, GA, Immucor is a global leader in transfusion and transplantation diagnostics that facilitate patient/donor compatibility worldwide. Our mission is to ensure that patients in need of blood, organs, or stem cells get the right match that is safe, accessible, and affordable. The result is life changing for a patient in need of a transfusion or transplant. Our new corporate identity illustrates the right match of donors with patients in need of blood or an organ as well as Immucor’s partnership with healthcare organizations in need of innovation and productivity. With the right match, we can transform a life together.

As a Post Market Surveillance Specialist, you will be responsible for assuringtimely complaint initiation, investigation/analysis, and complaint closures. Evaluates documentation for completeness and consistency and executes additional actions as necessary to close the complaint file. This is an hybrid role with one day on-site in Norcross weekly.

Are you familiar with Immucor products? Do you have blood bank experience? Do you have advanced Excel experience? If yes,we want to hear from yo u. Apply today!

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .

Post Market Surveillance Specialist (Data analysis/ Investigations/ Risk Management)

Responsibilities

As a Post Market Surveillance Specialist, you will be responsible performing post market data analysis, investigation, trending and documentation creation/review, inclusive of complaints, post market surveillance and risk management. Assists with the regulatory assessment for MDR/Vigilance and reporting.

Specific duties for this manufacturing operations compliance role include:

  • Reviews and approves customer complaints that are investigated by Technical Support.

  • Reviews and approves Product Investigation summaries and service calls.

  • Provide feedback and guidance to Technical Support and Product Investigation regarding written communications and investigations.

  • Monitors progress of root cause investigations and confirmed complaints investigations.Assigns corrective and preventative actions to responsible department.

  • Provides supplier notification of adverse trends or significant issues which are identified through complaint investigations.

  • Prepares customer letters summarizing complaint investigations. Prepares customer communications, technical bulletins, and quality directives for internal and/or external customers.

  • Initiates hold alerts for nonconforming products. Performs product impact assessments for complaints representing a potential non-conformance or product deficiency

  • Recognize complaint trends, potential product problems and potential recalls, and communicate them to management.

  • Initiates potential MDRs and BPDs when indicated.

  • Prepares monthly, quarterly, semi-annual, or ad-hoc trending reports on site product complaints at all levels of detail (e.g. product level, country, user level).

  • Participates in the preparation of post-market surveillance plans and reports according to the applicable procedures and schedule.

  • Performs risk assessments for complaints representing a product deficiency. Facilitate risk analysis and assessment per risk management procedures, monitoring and compiling data from adverse events, customer inquiries, complaint records, CAPAs, deviation reports, stability reporting, non-conformance reports, post-market surveillance,etc.

  • Participates on product life cycle teams; including commercialization teams for new products.

  • Supports the management of the supplier questionnaires (where Immucor Inc is a supplier).

  • Performs periodic surveillance of the instrumentation installation activities.

  • Assists during FDA, ISO or other third party or internal audits.

  • Facilitates the Complaints Review Board Meeting

Post Market Surveillance Specialist (Data analysis/ Investigations/ Risk Management)

Qualifications

The Post Market Surveillance Specialist must be to work and interact effectively and professionally with and for others throughout various levels of the global organization. They must be detailed, solution-oriented, proactive, and self-managed.

Specific qualifications for this role include:

  • Bachelor’s degree (BS/BA) from four-year college or university; or equivalent combination of education and experience.

  • Advanced experience creating excel spreadsheets for data analyses, preferred

  • American Society of Clinical Pathologists (ASCP) Certification desirable. Statistical analysis experience desired.

Post Market Surveillance Specialist (Data analysis/ Investigations/ Risk Management)

IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITY/FEMALE/DISABILITY/VETS; DRUG FREE WORKPLACE

RESUMES SUBMITTED TO IMMUCOR FROM THIRD PARTY RECRUITMENT FIRMS WILL NOT BE CONSIDERED.

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Immucor offers a comprehensive benefits package available on the start date of your employment, including:

  • Medical, prescription, dental, and vision insurance – we offer multiple plan options so you can determine which best suits your needs and the needs of your dependents

  • Wellness program

  • STD/LTD/Life insurance all 100% company paid

  • Voluntary life/accident/hospital indemnity insurance for yourself, spouse/domestic partner and dependents

  • Tuition reimbursement

  • Company matched 401k plan

  • Vacation/Company & Personal Holidays/Sick days

Where permitted by applicable law, all Immucor new hires must be fully vaccinated against COVID or have an approved Immucor exemption. Proof of vaccination status will be required no later than first day of employment.

Job Locations US-GA-Norcross

Job ID 2022-3054

Category Quality

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