Overview
MEDICAL DEVICE EXTERNAL QUALITY MANAGER (ONSITE) Jobs in North Chicago, IL at AbbVie
Vacancy Name
Quality Manager
Vacancy No
VN309
Department
Quality
Location
Zeeland
Employment Type
Full-Time
Company Overview
Aurorium is the materials innovation partner that helps global manufacturers harness the power of possibility to make the world a better place. Their specialty ingredients and high-performance materials enhance quality of life, support health and wellness, and enable customers to deliver value-added solutions.
Key industries served include healthcare, personal & home care, mobility, infrastructure, and paper & packaging. A Responsible Care® company, Aurorium follows the highest regulatory standards across all manufacturing facilities. The company’s global integrated supply chain offers the customer product consistency, easy access, supply security, and reasonable turnaround on delivery. Aurorium is committed to operating at the highest levels of manufacturing consistency, quality control, and safety.
Description
The Quality Manager is the site’s primary leader for all Quality Assurance (QA) and Quality Control (QC) activities. They are accountable for developing, implementing, and continuously improving a robust quality management system that adheres to standards such as ISO 9001 and applicable Good Manufacturing Practices (GMP). This role ensures product quality aligns with customer expectations and regulatory requirements, while also managing investigations into internal and external quality issues.
Job Details
Role Specific Responsibilities:
Has responsibility and authority to oversee the development, implementation, review, maintenance, and management of the on-site Quality Management System
Holds decision-making authority at site level regarding material and product quality
Approves all plant procedures and any changes that may affect product quality
Collaborates with Regulatory Affairs on all regulatory aspects of the product including registration, licensing, DMFs, CEPs, analytical method validation, process validation, etc.
Oversees the MOC Management of Change, OOS Out of Specification, Deviation and CAPA Corrective and Preventive Action programs
Manages and facilitates all compliance activities for ISO, CGMP, etc.
Maintains SOPs and forms on the Aurorium DMS Document Management System
Manages and conducts plant-wide CGMP training to assure compliance with all regulations
Ensures efficient and safe operations of the lab and coordinates daily workload to ensure testing and releases are conducted in a timely manner
Manages/coordinates flow of documentation from Production to Quality to ensure timely review of documents
Audit Site operations against existing SOPs and methods for conformance (e.g. technical quality of work, methods and instrumentation). Write audit reports and recommend corrective action
Maintains SOPs and Forms on the Aurorium DMS Document Management System
Trends data and reports potential problems to site leadership team.
Oversees Stability Program and Annual Product Review for the products supplied by the site
Coordinates all on-site quality-based regulatory and customer audits and provides written responses as necessary in a timely fashion
Leads the investigation of all customer complaints/dissatisfactions and provides timely updates and reports as required
Responsible for auditing contract laboratories and processors including evaluation of proposed new and alternate raw material suppliers.
Develops and implements new and/or improved programs to assure continual Quality improvements
Manages the Quality department budget (not including salaries), through direct involvement and management of QA and QC personnel
Manages Quality Agreements with both suppliers and customers, and acts as the primary point of contact for customer quality-related inquiries
Performs other duties as assigned
Compliance:
Complies with company Health, Safety and Environmental policies, procedures, and arrangements
Reports all Health, Safety and Environmental accidents, incidents and near misses promptly
Acts in a safe and responsible manner at all times
Problem Solving and Innovation:
Active participation in continuous improvement activities
Participates in problem-solving
Takes responsibility and ownership for own learning and development in the spirit of continuous improvement of both self and the business
Assists in the training, mentoring, and assessment of other team members
Exercises autonomy and judgement subject to overall direction or guidance
Knowledge, Skills, and Abilities:
BS degree in Chemistry or Engineering with a MS preferred
Internal auditor training
Proficiency in ISO 9001 and CGMP
ASQ certification (CQE, CQA or CMQ/OE) preferred
Lean and/or Six Sigma certification preferred
7+ years’ experience in a CGMP environment – Food, API, Excipient or Pharmaceutical manufacturing
3+ years’ experience in a supervisory/lead role
Hands-on experience in an analytical chemistry lab
Ability to solve practical problems and deal with a variety of changing situations
Strong time management and prioritization skills
Computer literate: MS Word, Excel, Access, PowerPoint; SAP experience preferred
Technical/Professional Knowledge and Skills analysis
Embodies the core values of Aurorium:
credible: keeps their word and honors their commitments, acts with integrity, and holds themselves accountable to their decisions and actions
outcome-oriented: adheres to an unparalleled standard of excellence in everything they do, to deliver results with real impact
driven: passionate about delivering authentic, world-class experiences that engage customers and inspire greatness
empowered accountability: empowered to achieve common goals and accountable for delivering performances and results that exceed standard.
If you have the energy, drive, and passion for joining the Aurorium team, we would love to hear from you. Apply today!
Aurorium offers competitive total compensation packages, including benefits such as medical, dental, vision, life, 401(k), disability insurance, flexible spending accounts, health savings accounts, paid time off, and paid holidays.
Aurorium is a global Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of and will not be discriminated against based on gender, sexual orientation, gender identity, race, ethnicity, religion, age, veteran status, disability status, genetic information, or any other protected category. #LI-Onsite
Status
Active
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Title: MEDICAL DEVICE EXTERNAL QUALITY MANAGER (ONSITE)
Company: AbbVie
Location: North Chicago, IL
