Sterility Assurance Manager

RTP company is recruiting for a Manager of Sterility Assurance. You will be responsible for the Sterility Assurance lab operation, biocompatibility studies and re-usable cleaning/sterilization processes. Supervision and management of the Sterility Assurance Lab personnel. In charge of the sterilization release operation for various plants. Perform biocompatilibity and re-usable cleaning/sterilization evaluations and/or validations for new product, product modification and products' introductions to new markets.

Major duties and responsiblilities include:

* Supervision of lab operations.
* Management & development of lab staff.
* Maintain Quality systems and establish laboratory and sterilization procedures in compliance to FDA regs and ISO requirements.
* Represent Sterility Assurance for biocompatibility evaluations and/or validations of client's projects: new products, existing product improvement, new market introduction. Develop protocols, technical reports and directs validations, as necessary, for biocompatibility studies.
* Maintain biocompatibility related procedures current per relevant domestic and International standards.
* Develop and maintain a biocompatibility database for client's products to be used and reference in product evaluations.
* Represent SA for re-usable cleaning/sterilization evaluations and/or validations, including new products and existing product improvement, and new markets. Develop protocols, technical reports and directs validation, as necessary, for re-usable cleaning/sterilization.
* Assist in supplier/client plants' quality assessments, as required.
* Assist in preparation of budget requirements and regulate the department to budget.
* Work closely with other departments such as R&D, Marketing, RA, in understanding, developing and executing statistically designed experiments, validations, technical reviews and reports as required for new products, product modificaiton and new market introductions.
REQUIREMENTS
You will have a strong background in Regulatory, cGMP, QSR, knowledge base. You will have extensive statistical knowledge (DOE, SPC, Hypothesis testing, Sample Comparison) as well as supplier auditing skills (ASQ CQA preferred). A background in Sterilization (EO and gamma radiation) is required.

Bachelors degree in a Scientific field. MS or MBA preferred. 7-10 years experience along with a Six Sigma certification (Green or Black Belt).

Qualified candidates, send your resume to me as a MS Word attachment. Please include salary requirements.