Microbiologist

Apply by eMail:do_not_reply@invalidemail.com

Description:
  MICROBIOLOGIST
Orthovita, Inc. is a biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products for use in orthopedic and related surgical procedures.
 
We have an immediate opening for a Micorobiologist. Responsible for operational aspects of Microbiology, Environmental Control and Sterilization. 
 
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manages the microbiological testing of products for sterility, bioburden, bacterial endotoxins, and environmental monitoring.
Ensures quality system and Good Laboratories Practices (GLP) compliance and approves new and revised SOPs related to Microbiology, Environmental Control, and Sterilization. Responsible for ensuring that all appropriate training in relevant Orthovita quality system procedures, standards, FDA QSR, the European Medical Devices Directive, company policies and procedures, and Safety is conducted. 
Ensures that all employees under their direction meet the qualification requirements for the job to which they are assigned.
Analyzes and interprets microbiological testing data. Establishes alert and action limits and prepares professional trend reports for management review. 
Recommends preventive and corrective actions regarding microbiological issues. Provides input for regulatory submissions pertaining to aseptic processing, sterilization validation, environmental monitoring, etc.
Performs assigned internal, subcontractor, pre-clinical and human clinical site quality system audits in accordance with cGMP/QSR and ISO/EN requirements.
Prepares budgets, evaluates new equipment and makes purchasing recommendations.
Prepares and coordinates sterilization validation master plans, protocols, and validation reports.
 
  SKILLS, EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
A Bachelors degree in Microbiology or Life Science from a four-year college or university; or five to seven years related experience and/or training: or equivalent combination of education and experience. 
 
Ability to read, analyze, and interpret complex documents. Ability to respond effectively to sensitive inquiries or complaints. Ability to write speeches and articles using original and innovative techniques and style.   
 
Ability to comprehend and apply principles of calculus, modern algebra, and statistical theory. 
 
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.)
 
Proficient in Microsoft Office Suite skills including electronic mail, record keeping, routine database activity, word processing, spreadsheets, graphics, etc.
 
TRAINING AND STANDARD OPERATING PROCEDURES Employee is required to participate in all in-house training and education programs as instructed by their Manager. Upon hire and annually thereafter, all employees are required to read, adhere to and acknowledge receipt of Orthovita’s Corporate Governance Documents. 
 
Orthovita offers competitive compensation with an extensive benefits package. If you are interested in this position, please visit our website www.orthovita.com to complete an on-line application.
 
Orthovita is an equal opportunity and Affirmative Action employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, sexual orientation, national origin, disability or handicap, or veteran status. We encourage minorities, females and veterans to apply. NO PHONE CALLS OR RECRUITERS!!
Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Orthovita via-email, the internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Orthovita.  No fee will be paid in the event the candidate is hired by Orthovita as a result of the referral or through other means.
 
 
 
 
 

Apply by eMail:do_not_reply@invalidemail.com

Job Created: Sat Nov 07 2009 07:31:53 AM
Last Modified: Sat Nov 21 2009 07:42:05 AM