Manager, Quality Control Microbiology - Boulder, CO | Biospace
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Manager, Quality Control Microbiology

MedImmune, LLC

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Location:
Boulder, CO
Posted Date:
4/27/2017
Position Type:
Full time
Job Code:
R-005886
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Boulder, Colorado, United States
Job reference: R-005886

Posted date: Apr. 06, 2017

                                                     
                           


 

   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 Manager, Quality Control Microbiology in Boulder, CO, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives.  

   Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.  

   Main Duties and Responsibilities  

   You will be responsible for accountability and oversight of daily operations within the Quality Control Microbiology laboratory, with potential to work rotating weekend coverage at the Boulder Manufacturing Center.  You will be responsible for direct supervision of experienced and entry level Quality Control staff members.  Responsibilities include staff communication and coaching; professional development; compensation and performance reviews; goal setting; training; and other leadership activities utilizing AZ/ MedImmune management tools and policies.  

 

   ~bsp  

   Assist with scheduling of sampling activities, analyses, personnel, and equipment to ensure timely completion of routine testing and projects.  Review data generated in the laboratory and release results.  Oversee equipment maintenance ensuring routine PM and/or calibrations are completed.  When required, you will perform and/or assists with Deviations, Laboratory Investigations, and/or Out-of–Specification investigations, assisting with identification of root cause and appropriate Corrective/Preventive actions.  Oversee implementation and maintenance of Quality Control Systems and ensure cGMP compliance.  

   Represent QC at internal and external regulatory audits during laboratory tours and QC process discussions/requests.   Assist and oversee generation of Standard Operating Procedures, Analytical Methods, and protocols, as well as, validation and verification of test methods and new equipment validation.  Recognize, troubleshoot, and resolve moderately complex problems with equipment or individual assays.  You will be responsible for on-time delivery and/or closure of QC-owned deliverables (Deviations, laboratory investigations, testing plans, controlled document revision and review, group metrics, etc.) with help of other management and technical specialists as needed.  Assure trending is performed as required for analytical results, OOS, analyst performance, etc.   Identify and deliver lean and efficiency initiatives and projects for QC processes.   Assist with ensuring area of responsibility is maintained within budget.  Participate in multi-functional project teams as organizational representative, as necessary.  

Requirements

   Essential Requirements    
       
  •      Bachelor’s degree in Biology, Chemistry, or related scientific field    
  •    
  •      Ten years of Quality Control experience in pharmaceutical or biopharmaceutical industry, with at least 4 years of direct supervisory/management experience    
  •    
  •      Experience within a cGMP Microbiology laboratory environment    
  •    
  •      Knowledgeable of the current Code of the Federal Regulations (CFRs) and Current Good Manufacturing Practices (cGMPs), and global regulatory agency requirements.    
  •    
  •      Possesses strong written, verbal, and interpersonal skills.    
  •    
  •      Ability to work weekends on rotation    
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    Desirable Requirements    
       
  •      Ability to troubleshoot and solve routine issues related to oversight/supervision of the organizational unit, seeking organizational management support as needed    
  •    
  •      Ability to provide day-to-day oversight and supervision of organizational unit with minimal direction but able to apply common sense understanding and knowledge of when to stop and seek input and approval from management    
  •    
  •      Ability to collaborate effectively under limited supervision and with Senior Management to identify solutions and optimize strategies for implementation    
  •    
  •      Ability to clearly and effectively communicate within and outside the organization, including providing direction and guidance to direct reports based on general policies and management guidance    
  •    
  •      Ability to effectively allocate resources to accomplish organizational objectives in alignment with staff development plans and goals    
  •    
  •      Ability to successfully work in ambiguity and be flexible and adaptable with changes    
  •    
  •      Ability to apply principles of logical or scientific thinking to a wide range of practical problems    
  •    
  •      Ability to identify and implement efficiency initiatives within the organization    
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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.  

 

   *LI-MEDI  

   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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.