AbbVie Sr. Manufacturing Quality Assurance in Lake County, Illinois
Major Job Responsibilities: * Review/approve batch record packets and associated documentation. * Provide quality approvals in the materials management system as defined by procedures. * Write/review/approve exception documents and corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements. * Review/approve clinical documentation. * Write/review policies/processes/procedures and related documents. * Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, and internal Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues. * Lead/participate with support groups in developing/prioritizing QA activity timelines. * Actively monitor the effectiveness of processes and quality of project work with management, and propose and execute quality/process improvements.
Minimum Education Requirements: * Bachelor’s degree or equivalent experience is required; typically in life sciences or engineering. Minimum Experience Required: * A minimum of 4 years experience in Quality Assurance or related field. Preferred healthcare industry and specific experience in quality function. Experience in the following areas: * Microbiology and associated testing * Hygiene and hygiene monitoring * Manufacture of parenteral dosage forms * Applying aseptic and/or sterile manufacturing techniques Preferred but not required: * Experience in protein and Antibody Drug Conjugate (ADC’s) analytics. * Manufacture of Oral Drug Product * Manufacture of Active Pharmaceuticals * Strong understanding of US and international regulations for quality systems and compliance. With an emphasis on Biologic regulations. * Experience in coordination and planning of complex activities. * Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities. * Ability to build and maintain credibility across functional disciplines. * Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues. * Ability to identify and resolve complex problems through effective use of technical and interpersonal skills. * Capable of clearly presenting and justifying quality requirements throughout all levels of management. Other requirements: Accreditation by a professional body is highly desirable. * Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).
Job Classification: Experienced
Job: QUALITY ASSURANCE
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Travel: Yes, 5 % of the Time
Req ID: 1705224
Equal Opportunity Employer Minorities/Women/Veterans/Disabled