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Sr Associate I, Quality Assurance (Quality Engineering) Durham United States,  

Biogen (company)

Posted on : 24 June 2017

Project Description

Job Description
  • The Sr. Associate I in Quality Engineering (QE) is responsible for the Drug Substance & Drug Product oversight of key functional, tactical, and operational aspects within Quality Assurance at the company Research facility.
  •  The Sr. Associate I responsibilities include, but are not limited to: 
  • Review of GMP raw data for compliance, review of GMP documentation, review of validation protocols (equipment, cleaning, and automation), review/approval of GMP procedures, identify gaps in existing Quality systems and propose solutions to site management. 
  • Assist in the development and implementation of Global Quality Systems, leading site and global initiatives, provides oversight with respect to the proper administration and adherence to all company policies and procedures; adherence to all regulatory licenses and regulations, interfacing with key Quality. Manufacturing, and Engineering customers, and coordination of investigations impacting the RTP site; performs review of GMP documents and raw data for compliance to applicable procedures as well as regulatory and corporate guidance documents. 
  • The Sr. Associate I QE may facilitate internal compliance audits; support external inspections from regulating agencies, assess and approve discrepancies from site, corporate, and regulatory guidance. 
  • The QE Sr. Associate I will also support the Manager for activities related to interviewing, hiring and training of employees, as well as compliance with training policies.
  • The Sr. Associate I of Quality Engineering will ensure that Quality systems within the Quality Assurance department remain in compliance with company and industry cGMP standards. Additionally, the Sr. Associate I will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture. 
  • Failure to achieve results or erroneous decisions/recommendations may result in compliance issues, cause significant delays in schedules, cause financial repercussions, and/or may result in the re-allocation of additional, unplanned resources.

Principal Accountabilities supporting Drug Substance & Drug Product site:
  • Facility, Utility, Equipment and Automation Validation review/approval of procedures, protocol/report approval.
  • Review/approval of change control documents and activities associated with change control implementation
  • Facility and equipment controls and release during shutdown, construction, product changeover.
  • Provide cGMP guidance and quality support of Manufacturing on the floor issues, including assistance with deviation initiation.
  • Observe critical manufacturing process operations to ensure adherence to internal procedures and regulatory guidelines. 
  •  Review of PM workorders and CM work orders as applicable to cGMP systems
  • Proactive identification and resolution of both technical and compliance issues/gaps
  • Develops and implements aspects of various Quality Systems/System Improvements.
  • Performs QA review of alarm assessments for cGMP equipment

  •  8+ years of Quality-related experience in the following disciplines:
  • GMP review of validation documentation and strong knowledge of equipment/facilities/utility systems
  • Knowledge of FDA/EMEA regulations and compliance.
  •  Robust knowledge of current global Regulatory Quality requirements
  • Agency inspection experience
  • Previous experience with Quality Systems development
  • Technical expertise in sterile parenteral & biologics fill/finish and visual inspection operations
  • Expertise pertaining to the application of isolator technology supporting sterile fill/finish operations 

Bachelor s Degree in Engineering or related Life Science or Technical discipline 

About Us 
  •  Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. 
  • Our company  is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer s disease, Parkinson s disease and amyotrophic lateral sclerosis (ALS).  
  • Our company  also manufactures and commercializes biosimilars of advanced biologics.   
  • Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.  
  • Our company  was founded in 1978 and today serves patients in nearly 70 countries.  
Our Science 
  •  We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.  
  • To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.  
  • For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. 
  •  Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. 
  • We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer s disease, Parkinson s disease, and ALS. 
  • As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.  
  • Our company  is revolutionizing biologic manufacturing, developing the industry s most advanced plants and processes. 
  •  This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.  
Our Corporate Citizenship 
  •  The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. 
  •  As a company, we are focused on improving science education and limiting the impact of our company on the environment. 
Job Segment:  Biotech, Quality Engineer, Engineer, Construction, Science, Engineering, Quality                       


Research Triangle Park NC US

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