GxP Quality Support Lead

Position Summary
This position will be a member of the GxP Rapid Response team initiatives for Central Quality System and Compliance. The Quality Support Lead will also serve as a cross-functional member for key initiatives in Central Quality Systems and Compliance.
The Quality Support Lead is responsible for maintaining and improving Quality System processes to ensure. Quality initiatives are completed and delivered on time. Quality Support Lead requires excellent communication skills and someone self-motivated and a self-starter to drive for implementation and Quality issues. The Quality Support Lead must possess strong verbal and written communication skills and sound organization skills applicable to planning, reporting, and archiving/knowledge transfers

Job Duties & Responsibilities

  1. Work with Subject Matter Experts supporting process compliance/ improvements to Quality Management System Elements such as CAPAs, Deviation, Change Control, Supplier Quality Management, Audit, Inspection, and Notification to Management
  2. Be an individual contributor supporting the implementation of Quality process initiatives
  3. Serve as active partner across GxP groups, providing support and consultation to our Quality Business Partners and Business customers
  4. Perform other related duties and special projects as required or requested.
  5. Support Quality programs in accordance with Health Authority regulations.

Essential Qualifications
4 to 8 years of experience in biopharmaceutical/pharmaceutical or related industry with strong background
Hands-on experience in working in agile or fast paced teams
Experience participating in cross-functional projects
Proficiency with Microsoft Office Suite (Outlook, Excel, Word, Smarts sheets and box etc.)
Strong interpersonal communication skills
Demonstrated passion and skills for problem solving
High attentiveness to detail
Proven ability to quickly learn new information and communicate requirements to the appropriate individuals.

Preferred Qualifications
Advanced quality certification strongly desired (i.e., Six Sigma Green Belt, Certified Lean Expert, etc.)

Bachelor's degree in chemistry, life sciences, or related field with strong background

Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
Published 3 days ago
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