Quality Specialist

Apply by eMail:do_not_reply@invalidemail.com

Description:
 
Quality Specialist
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 Quality Specialist, responsible for the review and correctness of batch records including but not limited to raw materials, in process and finished goods. Work closely with the manufacturing, logistics, documentation, and quality assurance departments to coordinate daily work flow processes and use statistical techniques to monitor performance of the department as it relates as a whole to completing tasks. Ability to assess work assignments and various projects, including personnel resources, and to adjust for unforeseen problems and roadblocks. Understanding of Quality Systems and how it relates to the functions required to review, maintain and release finished goods.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Experience working in a medical device &/or pharma company in an ASEPTIC manufacturing environment. Working closely with a cross functional group consisting of manufacturing, logistics, regulatory, documentation, and quality assurance.
Batch record review, analysis of statistical data, and evaluation of results.
Understanding and ability to conduct routine and non-routine analysis of raw materials, in-process, and finished formulations according to established procedures.
Develop and maintain inspection, testing, and work flow status using databases, Excel, or similar tools.
Perform Quality functions dealing with system performance such as: NCMR’s, Preventive and Corrective Actions, data presentation including trends and statistical analysis.
Author and revise Quality documents including SOP’s, QIP’s, RIP’s, and TOP’s. 
Prepares and maintains quality records in a pristine manner.
Participates in execution of written method validations and assist in writing reports.
Effective at presentation to small and large groups of internal and external customers.                               
 
 
ORGANIZATIONAL RELATIONSHIPS: Reports to the Quality Control Supervisor.  
 
WORK SCHEDULE/HOURS: This position works regular business hours M-F. Occasional travel required (up to 30%).
 
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Individuals will work in well lighted, heated and/or air conditioned indoor office/lab environment with adequate ventilation. May occasionally work near moving mechanical parts.
 
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: Wed Oct 21 2009 06:44:29 AM
Last Modified: Fri Nov 20 2009 07:37:46 AM