About The Position

Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise. In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our talent pipeline and considered for future opportunities.

Requirements

  • Bachelor’s Degree, preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries.
  • 6+ years of total relevant experience, including 4+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device, biotechnology or related industry and 2+ years in compliance/auditing is required.
  • Must have a technical background, including an understanding of Quality Assurance audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.
  • Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support, and service and understand the principles of quality management
  • Excellent oral/written communications skills.
  • Must exhibit strong interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills, and sound judgment.
  • Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas

Nice To Haves

  • ASQ certification desired.

Responsibilities

  • Assesses compliance of systems, facilities, and procedures per applicable regulations, assuring compliance to regulatory requirements and AbbVie specifications.
  • Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained at the supplier or internal AbbVie site. For internal sites, formulates recommendations for corrective actions.
  • Participates in strategic initiatives to improve compliance to regulatory requirements and standards.
  • Collaborates with R&D QA to coordinate and conduct joint audits.
  • Communicates and coordinates supplier audit activities with internal stakeholders such as procurement, SQA, EQA, manufacturing sites and commercial affiliates as well as external stakeholders
  • Ensures audits are conducted according to the annual audit schedule.
  • Ensures no product launch delays or business interruptions due to supplier audit delays thereby assuring supply to AbbVie patients.

Benefits

  • paid time off (vacation, holidays, sick)
  • medical/dental/vision insurance
  • 401(k)
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service