Senior Specialist, Quality Assurance
4 days ago
We are seeking a highly skilled Senior Specialist, Quality Assurance to join our team at Organon & Co. This role will be responsible for ensuring the quality and compliance of our products, as well as providing technical advice and support to our external partners.
Key Responsibilities- Ensure the quality performance of external partners through direct oversight, support, and technical advice.
- Execute permanent audit readiness, track partner quality metrics, and provide coaching and training.
- Prepare, review, and track deviations and corrective and preventative actions (CAPAs).
- Support the evaluation and disposition of products, including temperature excursions and damages.
- Participate in global audits to assess competence, gaps, and reliability of external partners.
- Help support quality-relevant projects and ensure the quality and accuracy of documentation and record retention.
- Act as a liaison for contact and communications between partners and internal personnel.
- Support the preparation of metrics, procedures, and guidelines as needed.
- Bachelor's degree in a scientific or engineering field (preferred) or other related areas of study.
- At least two years of relevant post-degree work experience in a quality position, manufacturing, laboratory setting, or related industry experience.
- Good oral and written communication skills.
- Knowledge of GDP (Good Distribution Practice) and GMP (Good Manufacturing Practice) as they apply to the pharmaceutical industry or a related manufacturing environment.
- Interpersonal skills, including flexibility, partnership, and inclusion skills, as well as the ability to problem-solve.
- Broad experience in Quality Assurance and Quality Control (preferred).
Organon & Co. is a global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars, and touching lives with a diverse and trusted portfolio of health solutions.
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