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Posted: Saturday, March 11, 2017 1:43 PM

Job Description:/h3:
Job Title:
Quality Assurance Manager
Status:
Full time
Department:
Quality Assurance
Reports to:
Chief Executive Officer
Job Purpose:
The Quality Assurance Manager (QA Manager) is a vital position in the operations of Celltexs laboratory services. The primary responsibility of the QA Manager is to conduct and facilitate internal and external audits to assure compliance of products and processes to Celltexs specifications and satisfaction. In addition, the QA Manager assures that products, processes, facilities, and systems conform to quality standards and relevant governmental regulations (FDA).
Job Duties:
Review and improve quality system documentation; write and/or review Quality Assurance (QA) standard operating procedures to assess cGMP compliance on issues relating to sterile biologics manufacturing
Perform audits of manufacturing and quality control practices and procedures, including internal audits, vendor qualification audits, and audits of investigator sites
Supervise the QA Specialist on audit:related work, during final production and quality control record review, and during the release of finished products
Lead inspection and accreditation procedures as necessary, including leading and overseeing audit/ inspection preparation activities and remediation plans
Conduct weekly quality review meetings and prepare reports
Develop and conduct GXP and safety training courses for all staff annually, post:audits, and as necessary, and maintain staff GMP training records
Develop budgets and monitor expenditures related to Quality Assurance activities and programs
Manage recalls and returned products
Manage the document control system, including document issuance and retirement, and maintenance of document history files
Evaluate the adequacy and effectiveness of corrective and preventive action plans
Prepare, organize, track and perform QA review of FDA submissions to include: INDs, Annual Reports, Supplements, etc.
Provide interpretation of GMP/ GTP/ GCP regulatory requirements as they apply to Celltex
Skills/ Qualifications:
Strong interpersonal, leadership and communication skills; exceptional analytical and problem:solving skills with great attention to detail and precise organization and record:keeping practices. Must be familiar with GMP and FDA requirements, and possess knowledge of GMP documentation. Must be able to work flexible hours and before/after normal business hours on short notice.
Education/ Experience:
Bachelors degree in relevant engineering or biological sciences and at least 8 years of experience in biotechnology or pharmaceutical Quality Assurance, with at least two years in management or a supervisory Quality Assurance position. Previous FDA audit experience required.

Company Description:/h3:
Discover the healing power of your own stem cells(r)
Experience the latest advancement in medical technology. Celltex Therapeutics is the premier provider of regenerative medicine and stem cell therapy in the United States, and our services ensure that the disease:defying and revitalizing properties of your stem cells are available to you whenever you need them.

Source: https://www.tiptopjob.com/jobs/64602976_job.asp?source=backpage


• Location: Houston

• Post ID: 49425948 houston
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