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Home
> Biotech
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Director Of Quality Assurance |
| Eligibility : |
B.S. Degree in scientific discipline, preferable biology or chemistry, Master´s or Ph.D. |
| Location : |
Durham - NC North Carolina - USA |
| Designation : |
Director of Quality Assurance |
| Details :: |
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Management Recruiters Of Seneca |
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Scope:
We offer the potential to develop and commercialize novel and cutting edge therapies for cancer and HIV, the excitement of a small company environment where everyone’s contribution is important, and the potential to advance your career in a young and growing company.
This person will oversee areas of Quality Assurance and Regulatory Compliance for the manufacture of immunotherapeutics including audits, training programs, data and documentation reviews and analysis, preparation of SOP´s, and other projects as necessary.
Responsibilities:
Manage Quality Assurance functions to include hiring, training and development of QA personnel for the maintenance and establishment of Quality and Regulatory systems.
Oversee review and drafts of SOPs, protocols and final reports. Ensure that QA SOPs and cGMP documentation for areas of responsibility are adequate and current.
Work collaboratively with other departments to ensure compliance with cGMP processes and safety procedures for biologics manufacturing and readiness for regulatory inspections.
Review and approve completed batch records, test results, investigations and change control. Release final product for clinical use to meet project goals.
Conduct internal and external audits of manufacturing operations, testing laboratories and suppliers.
Manage critical raw material files and raw material quarantine and release program.
Manage company-wide cGMP training program.
Participate in Steering Committees and Planning Committees on relevant technical programs.
Stay abreast of QA and regulatory areas and communicate changes and issues to all levels of the organization.
Oversee discrepancy, corrective and preventive action (CAPA) and change control systems.
Participate on project teams for the design of new systems and procedures.
Oversee equipment validation/calibration activities.
Oversee the resolution of complex QA issues related to autologous immunotherapies.
Assist Manufacturing to ensure production processes comply with appropriate FDA and Country specific regulatory requirements (Health Canada).
Assist in technology transfer from R&D and Process Development (Automation) to GMP manufacturing under batch records and appropriate FDA and Health Canada regulatory compliance.
Assist in facility expansions for manufacture and other operations that meet the FDA and Health Canada regulatory requirements.
Work as an effective team member with others in Operations and R&D to identify and accomplish company objectives.
Other duties as required.
We offer a competitive compensation package along with outstanding benefits.
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A part of the MRI Network, specializing in placing QA, QC, Regulatory Professionals, Engineers and Research Scientists into Biopharmaceutical companies.
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| Salary : |
Not specified |
| Company URL : |
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| Last Date : |
2007-12-13 |
| Address: |
Management Recruiters of Seneca |
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