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Specialist, Distribution Quality Assurance
4 months ago
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
Purpose
Assure compliance with FDA current Good manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) regulations. Assure compliance with Corporate policies/procedures and provide guidance on operational processes, procedural issues and documentation content and adequacy.
Assess operations/distribution outages and deviations to determine compliance with specifications and procedures.
Responsibilities
Approve/initiate changes to Distribution Operations and QA procedures, facility and equipmentAudit Interface- FDA, supplier, customer inspection, corporateConduct product quality, diversion and distribution complaint investigationsManage warehouse temperature monitoring programInitiate exceptions reports in the appropriate databasePerform inbound quality inspections and usage decisionExecute domestic and international sales/recall reportsExecute placement and removal of QA Holds in warehouse management systemManage/Post supplier audit data in appropriate databaseManage market authorization process and Material Data ManagementQualifications
High school degree is required. Bachelors degree is preferred2-4 years in Quality Assurance, Process Support, Manufacturing, Distribution, Quality Control or similar area.Reviewing problem solving situationUnderstand manufacturing / distribution processProduct responsibility for compliance troubleshootingAudit interfaceCreativity in resolving issuesNegotiation skills with Mfg. / Distribution customers
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this postingbased on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more orless than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidandmay be modified at the Companys sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
