Quality Analyst

Apply by eMail:do_not_reply@invalidemail.com

Description:
 
Orthovita, Inc. located in the Great Valley Corporate Center in Malvern, PA. We are a biomaterials company with proprietary technology for the development and commercialization of synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications.
We have an immediate opening for a Quality Control Analyst.
This position is responsible for supporting a wide range of Quality functions including, but not limited to corrective and preventive actions, internal and external audits, validation support, product stability studies, and product testing. Participates on new product development teams to assist in implementing quality plans to ensure devices meet global design control requirements.
Requirements
Applicants should have a Bachelors degree from a four-year college or university in Biochemistry, Chemistry, Biology or related technical discipline and two years expererience; or equivalent combination of education and experience. Experience in a FDA and or EU regulated medical device, biologics, or pharmaceutical company preferred. Requirements: Knowledge and experience with routine laboratory equipment operations and functions such as: HPLC, FTIR, UV/VIS, Fibrometer, DSC, TOC, ICP, XRD, Titrators, Balances, pH Meters, etc. Experience in analysis of proteins using modern protein analytical techniques a plus. 
 
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Supports the internal corrective and preventive action (CAPA) system, ensuring that all required actions are investigated, documented, implemented and followed up in a timely and adequate manner according to company requirements.
Must have strong background in a FDA and ISO regulated environment with understanding of Quality System Regulations and how they pertain to the medical device industry.
Conducts internal and external audits of various processes against all Quality System Regulations.
Participates on new product development teams as Quality Assurance liaison to ensure devices meet global design control requirements.
Supports the product stability program, including product and package shelf life studies.
Develops methods and writes technical quality documents and reports including: SOP’s, QIP’s, RIP’s, TOP’s, Qualifications, etc.
Develops, executes, and reports on validation efforts for products, processes, and equipment.
Supports the customer complaint process when needed, working directly with regulatory and customers to resolve issues in a professional and timely manner.
Cross task backup of Quality functions.
SKILLS, EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
A Bachelor’s degree from a four-year college or university in a relevant life sciences curriculum. Required to have a minimum of three to five years direct Quality Assurance experience with a medical device or pharma company operating under US FDA and or/ EU MDD regulations. Strong background, experience and understanding of Quality Systems in organizations with on-site manufacturing activities in the medical device/pharma industry.
 
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
 
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.
 
 
Orthovita offers competitive compensation with an extensive benefits package. If you are interested in this position, please visit our website http://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 07:32:41 AM
Last Modified: Sat Nov 21 2009 07:42:11 AM