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AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Quality Control Laboratory Manager

Barceloneta, Barceloneta, Puerto Rico Req ID 2210723 Category Quality Assurance Division AbbVie

The Quality Control Laboratory Manager is responsible to ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QA Site Director.

 

Responsibilities

  • Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities
  • Member of the Laboratory Center of Excellence (COE)
  • Serves as the standalone laboratory systems and site Maximo administrator
  • Reviews and approves raw materials and commodities including ERP approval
  • Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs
  • Qualification and validation protocol writing, review, and approval
  • Actively participates in Periodic Validation Reviews, Annual Product Reviews, internal audits, and process data reviews
  • Provides front room and laboratory SME support during regulatory agency and internal inspections
  • Manages change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests
  • Leads the implementation of Quality-related projects including metrics

  • Bachelor’s degree in Science is required.
  • Must have at least 10 years of pharmaceutical Quality Control experience
  • Strong technical knowledge in Raw Material compendia testing, verification, and interpretation.
  • In-depth knowledge in analytical instrumentation, technique, and problem-solving
  • Ability to drive a large group of people to keep them motivated while increasing performance
  • Strong knowledge in bioanalytical testing such as ELISA, CESDS, TNF HPLC, etc.
  • Demonstrated leadership of a highly complex, fast-paced program demonstrated critical thinking, agility, and change management.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
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