ThinkCentric

Associate Director Quality Control

How to Apply for this Job
Company: ThinkCentric Contact Name: Donna Steiner Email your resume (Click Here) Use one of the above methods to apply for this job.

• Job ID:
• Date:06/09/2008
• Location:
• State:New Jersey
• Degree:B.S./B.A.
• Current Professional Level:Sr. Director/Director
• Salary:Not Specified   Why?

Job Types:

Methods Development/Validation, Product Testing/Release, QUALITY CONTROL (Drug or Device)

Job Description Responsibilities include, but are not limited to, overseeing all Quality Control Department activities, protein chemistry testing, activity by ELISA and flow cytometry, and potency by cell based assays, microbial and endotoxin testing, raw material testing, and environmental monitoring of the clinical production facility, in-process, release and stability testing of clinical grade products, review and release of QC data for drug substance and final drug product, preparation and qualification of reference standards, qualification and validation of test methods in accordance with USP/ICH guidelines, writing reports to support regulatory submissions and filings, reviewing and approving batch records and test results in support of Certificate of Analysis for product release to the clinic, overseeing QC budgeting activities and participation in additional projects/assignments as needed. Frequently interacts with subordinates, supervisors, customers, and functional peer group managers and/or with senior management. Interactions normally involve matters between functional areas, other company units, partners or customers. Responsible for overseeing all unit budget issues, prioritizing projects and allocation of personnel to meet project timelines. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises independent judgment within broadly defined practices and policies in selecting/developing methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules, and performance requirements are met.

Required Skills M.S. with 5+ years of managerial experience in Quality Control. The incumbent must be computer literate in MS Windows-based applications, possess excellent communication skills, including the ability to speak, write and understand English to comply with written procedures, instructions, SOPs and other documents.

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