Product Support Associate II

Grifols Shared Services North America, Inc

San Diego, CA 92108

Posted 3 weeks ago

Job Description

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.


**Summary:**


Product Support Research Associate 2 The QA Complaints Technician runs assays to support investigations, performs investigation into NAT assay related complaints, participates in CAPAs and performs work related to their area of expertise (for details see Primary Responsibilities). This role also maintains laboratory equipment and works collaboratively with interdepartmental teams to ensure investigations are completed and closed out in a timely manner.


**Primary responsibilities for role:**


? Responsible for running assays to confirm/investigate customer complaints.


? Investigation: Supports complaint investigation through interfacing with field representatives to acknowledge, document and perform basic investigation into root causes.


? Coordinates return of affected material to support complaint investigation


? Conducts review QC data and Non-conformance reports


? Drafts investigation reports to support final closure of complaints and submits for review and approval


? Potential Health and Safety Complaints Evaluation/Reporting: Assists in evaluating the complaints for potential health hazard as high priority within short timeframes


? Device History Records Review: Conducts review of DHR documentation including but not limited to batch records


? CAPA: Supports CAPA executions under guidance


? Maintains laboratory equipment in a calibrated state and completes necessary documentation


? Responsible for taking regularly inventory and ordering lab supplies


? Audits: Assists in Audit preparation as needed


? Training: Completes training in a timely manner. Maintains training records.


**MINIMUM REQUIREMENTS** :


Basic writing skills, including writing investigation reports with supervision. Basic skills in Excel, Word, Power Point, Statistical software. Knowledge of GMPs. Effectively works with cross functional teams both on site and in the field. Strong organizational skills and attention to detail. Good communication skills (in both written and oral formats). Ability to multi task and reprioritize projects based on business need


**Education:**


Minimum: HS Diploma with 5 years of relatable experience in biology, chemistry, biochemistry or biomedical engineering field


**Experience:**


Minimum of 5 years of relatable experience with HS Diploma. Associate degree with 3 years of related lab experience or bachelor’s degree with 1 year related work experience in lab setting is highly preferred


**Equivalency:**


Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.


**Occupational Demands:**


May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.


**EEO Minorities/ Disability/Veterans**


Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.


**Req ID:** 436787



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