Quality Assurance Product Review Specialist III

2 weeks ago

Waco, Texas, United States AbbVie Full time
Job Overview

Company Overview:
AbbVie is dedicated to the discovery and delivery of groundbreaking medications and solutions that tackle significant health challenges today while preparing for the medical needs of tomorrow. Our goal is to make a substantial difference in the lives of individuals across various critical therapeutic domains, including immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics portfolio. For further details about AbbVie, please visit our official website.

Position Summary:

This role is pivotal in the evaluation of finished and semi-finished products, as well as compounding Batch Records for all items produced and/or packaged at the facility. The incumbent will ensure adherence to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). This position entails performing Quality Assurance assessments of product documentation to facilitate the final disposition process and coordinating training within the department.

Key Responsibilities:
  • Conduct real-time reviews and approvals of records by Quality Assurance on the production floor, including finished products, semi-finished products, and compounding Batch Records.
  • Possess a thorough understanding of cGMPs and procedural requirements relevant to the area of responsibility, serving as a resource for operators and other personnel to ensure compliance.
  • Make informed decisions aligned with job responsibilities, regulations, procedures, and policies, providing necessary feedback on cGMP documentation.
  • Collaborate with Operations to resolve quality issues promptly.
  • Authorize re-work and in-process retest forms, along with any other documentation requiring Quality signatures.
  • Engage in continuous Gemba walks within the operational area as part of the batch review process.
  • Complete all required training for the role, including company-mandated and position-specific training.
  • Assist in the ongoing training of both new and existing personnel as appropriate.
  • Identify and assess events that deviate from established procedures or cGMPs, making decisions consistent with job responsibilities.
  • Empowered to make Quality-related decisions.
  • Participate in Operation area T-2 meetings.
  • Support OPEX initiatives and pursue process innovation and continuous improvement.
  • Review documentation and collaborate with Production to identify defects and manufacturing trends.
  • Provide insights and suggestions to aid in the analysis and resolution of Production challenges.
  • Prepare necessary documentation regarding batch disposition for international sites as required.
  • Identify and resolve all discrepancies in batch records to prevent regulatory implications.
  • Perform Quality Assurance issuance of all batch-related documents for manufacturing, production, validation, and quality assurance departments.
  • Issue batch records to support manufacturing and production, ensuring accuracy, compliance, and adherence to Data Integrity and current Good Manufacturing Practices.
  • Assist the Documentation Department in preparing, assigning, and issuing logbooks for the facility.
  • Undertake additional duties as assigned.
Qualifications:

Education:
High School Diploma or GED Equivalent is required. An Associate's Degree is preferred, or a Bachelor's Degree in a Science or Technical field is highly desirable.

Experience:
Minimum of three (3) years of experience in managing and reviewing documentation records. One (1) year of experience with Microsoft Word and Microsoft Excel is required; SAP experience is preferred. A minimum of three (3) years of experience in a cGMP environment is essential, with preference given to candidates with experience in an aseptic manufacturing setting.

Essential Skills and Abilities:

  • Strong analytical and problem-solving capabilities, with a keen attention to detail.
  • Excellent organizational skills with the ability to manage multiple tasks effectively.
  • Familiarity with Quality Assurance systems, cGMPs, ISO 13485, CMDRs, and EMEA regulations.
  • Self-motivated and detail-oriented.
  • Proficient hand-eye coordination and manual dexterity.
  • Strong mathematical skills; capable of performing basic arithmetic operations.
  • Ability to read, comprehend, write, and communicate effectively in English.
  • Capacity to follow detailed written or oral instructions.
  • Ability to collaborate and communicate professionally and effectively within a team-oriented environment.
  • Basic knowledge of Windows-based computer systems, including Microsoft Office, with a willingness to learn other computer-based systems.
  • Physically capable of lifting up to 40 lbs.

Additional Information:
AbbVie is an equal opportunity employer committed to diversity and inclusion. We aim to employ qualified individuals of the highest caliber without discrimination based on race, color, religion, national origin, age, sex, disability, or any other legally protected status.

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