Quality Control Microbiology Manager - West Chester, OH, US - West Chester, OH | Biospace
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Quality Control Microbiology Manager - West Chester, OH, US

AstraZeneca Pharmaceuticals LP

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Location:
West Chester, OH
Posted Date:
12/7/2016
Position Type:
Full time
Job Code:
R-000902
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:West Chester, United States
Job reference: R-000902
Posted date: Nov. 02, 2016


 

   At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Quality Control Microbiology Manager in West Chester, OH, USA,  you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.   

   The Quality Control Microbiology Manager will manage the activities and systems within the WCH Microbiology Laboratories to ensure compliance with cGMP, corporate standards, and other regulations and harmonize technology across all laboratories.  This role will also provide technical assistance to the PET’s and Technical groups and represent AstraZeneca in numerous industry groups dealing with Microbiological and general laboratory issues.  

   Main Duties and Responsibilities    
       
  •      Ensure cGMP compliance for the systems and processes within the QC Microbiological Laboratories at West Chester.    
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  •      Provide strategic and tactical direction and vision for ongoing and new projects across the facility in accordance with PETs and QA goals.             
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  •      Provide strategic direction and vision for all US and Global Laboratory system initiatives in accordance with corporate direction and as mandated by federal regulations.    
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  •      Maintain a group of technically competent microbiologists, capable of supporting assigned projects.    
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  •      Maintain a cGMP compliant laboratory.    
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  •      Assign projects to the microbiologists at all levels.    
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  •      Develop and validate microbiological methodology for new and existing products (USP, EP, JP methodology/guidance)    
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  •      Work closely with the PET Facilitator and PET ring members to ensure that their microbiological test needs are met.    
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  •      Evaluate and implement “state of the art” microbiological instrumentation and methodology at the WCH site.    
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  •      Perform and/or oversee the IQ/OQ/PQ of all microbiological instrumentation in the laboratories.    
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  •      Participate in FDA, EMEA and other Regulatory agencies inspections and provide response to their questions.    
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  •      Assist in the preparation and review of NDAs and SNDAs and International submissions.    
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  •      Participate on cross-functional teams; such as root cause analysis, assuming a leadership role in providing microbiological support to the team.    
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  •      Provide leadership and direction, as well as defined goals and objectives for direct reports and objective reviews of performance.    
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  •      Manage and develop capital and expense budgets for the QA Laboratories.     
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  •      Interact, on behalf of the QC Laboratories, with FDA, EMEA, TURKISH MOH, ANVISA, Canadian and Mexican Authorities during inspections.    
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  •      Provide leadership and direction for safety (SHE) initiatives in the WCH laboratories in accordance with corporate goals and standards.     
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  •      Provide direction and review of documentation associated with ongoing WCH site projects and initiatives.    
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  •      Provide support for maintenance and validation of various facility systems.    
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  •      Represent AstraZeneca interests as a team member on industry interest groups such as IPAC, PhRMA and PDA.    
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Requirements

   Essential Requirements    
       
  •      Bachelor’s degree in Biology, Microbiology or similar field.    
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  •      5 years of relevant Laboratory Experience (i.e. Pharmaceutical, Bio Technology).    
  •    
  •      Strong leadership capabilities.    
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  •      Strong interpersonal and supervisory skills.    
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  •      Demonstrated knowledge of cGMP as defined by 21CFR and EU Regulations.    
  •    
  •      Strong project management skills.    
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  •      Demonstrate understanding of Microbiological laboratory regulatory issues, especially environmental monitoring for sterile product aspects.     
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   Next Steps – Apply today!  

   To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.  

   AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.  

 

   ~bsp