Lab Sciences QA Manager

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Lab Sciences QA Manager page is loaded## Lab Sciences QA Manager remote type:
Sur place locations:
Everett, Washington time type:
Temps pleinposted on:
Publié il y a 23 jour(s) job requisition :
R102047
** Votre nouvelle entreprise !
** Chez Altasciences, nous travaillons tous à l'unisson pour contribuer à la découverte, au développement et à la fabrication de nouvelles thérapies médicamenteuses afin qu'elles parviennent plus rapidement aux personnes qui en ont besoin.  Quel que soit votre rôle, nous jouons tous un rôle important et vous aurez un impact significatif sur la santé et le bien-être des personnes dans le monde entier.

En respectant nos valeurs de développement du personnel, d'orientation client, de qualité et d'excellence, de respect et d'intégrité, nous cherchons à favoriser un environnement de travail passionné et collaboratif et nous sommes à la recherche de personnes talentueuses et enthousiastes, comme vous, pour rejoindre notre équipe en pleine croissance ! Que vous soyez un récent diplômé de l'université ou à la recherche de votre prochaine opportunité de carrière, il est temps de découvrir votre avenir chez Altasciences.

Nous sommes meilleurs ensemble et c'est ensemble que nous sommes Altasciences.
** About

The Role
** The QA Manager - Lab Sciences will be responsible for managing QA staff and resources to ensure efficiency across functions and sites in support of Lab Sciences operations. They will also be responsible for staff development and align with strategic plan needs. Their goal will be to integrate internal and external quality info inputs to quickly adapt and modulate QA activities.

The QA Manager - Lab Sciences will also utilize the application of risk assessment approaches within QA operations. Their goal will be to insure QA operations consistently meet internal and external timelines. They will be expected to be the second level of quality issue escalation / conflict resolution.
** What You'll Do Here
*** Maintain and monitor Key Performance Index related to QA pertinence and timelines.
* Manage the internal inspection program and ensure its completion on an annual basis.
* Identify and coordinate training within the group.
* Approval of audit plans to ensure they’re adequate and reflective of the needs identified from risk assessment strategies and various quality input information.
* Participate in the coordination and logistics of sponsors and/or regulatory authorities inspections.
* Prepare annual staff development plans, provide resources towards their completion, and perform adequate follow-ups through regular 1:1 staff meetings.
* Integrate quality inputs to modulate QA activities strategies and focus.
* Provide quarterly quality reports to the director on initiatives, risk assessment approaches, and results.
* Participate in the review of regulatory agency and/or sponsor’s deficiency letter to ensure they’re adequate, complete, compliant, and with the required courtesy and tact.
* Lead identified quality initiatives/projects identified through QMS, sponsor audits, and/or regulatory inspection audits.
** What You'll Need to Succeed
*** Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field with a minimum of five years experience, or equivalent combination of education and experience, in the pharmaceutical industry.
* Extensive knowledge of GLP and clinical sample analysis experience.
* Knowledge and understanding of the applicable US, Canadian, European, and ICH pharmaceutical regulations and guidelines.
* Detail oriented and ability to meet tight deadlines.
* Project management and coordination skills.
* Tactful, reliable, persuasive, dependable, consistent, flexible.
* Excellent written and oral communication skills.
* Software:
Microsoft Office.
** What We Offer
** The pay range estimated for this position is $90,000 - $115,000 annually. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.
** Benefits
*…