Global Biologics leader seeks a Validation professional to lead Material Qualification as Subject Matter Expert.
Top Initial Challenges:
1) Material Qualification responsibilities including:
a) Execute and maintain material qualification programs including study protocol design and SOP development
b) Determination of material suitability for use
c) Material Qualification Master Plan development, execution and maintenance
d) Monitor changes in MQ industry standards and make recommendations for improvement
e) Lead MQ change controls
f) Material risk assessments and gap assessments
2) Extractables and Leachables laboratory testing analysis
3) Investigate potential sources of particulate matter and identify methods for investigating trace contaminates
Long Term Challenges:
4) Implementation of best practices across sites, reviewing program SOPs, monitoring changes in industry/regulatory standards, assessment of change control as it relates to MQ, E/L and particulate matter.
5) Develop material qualification and quality control program for process equipment/system wear parts
6) Become a subject matter expert in material qualification representing site requirements at a divisional team level in the creation and maintenance of an Optimized Material Database.
Salary : Base will be dependent on your expertise and there are also strong benefits, bonus and relocation.
Location : Georgia
Contact : Apply below and/or at www.fpccareers.com and/or contact Ira Mann at firstname.lastname@example.org
Key Words: MQ, material qualification, particulate matter, risk, extractable, leachables, E&L, E/L
Qualifications (which should be clear on resume):
1) Expertise with Material Qualification and related d etermination of material suitability for use
2) 4+ years recent and related experience
3) BS in Scientific discipline and/or Materials Engineering (Masters preferred)
4) Extractables / Leachables experience
5) Direct experience in biotechnology and/or biologics (i.e., CBER regulated preferred)
6) Validation and protocol design experience
Since 1968, FPC is the leading supplier of SUREBONDER® brand products. We manufacture and supply a complete line of high quality...