Manufacturing Specialist II

Framingham, MA

Posted: 08/20/2019 Industry: Biotech/R&D/Science Job Number: 49407

Job Description


The manufacturing Specialist II uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.  

Core  Responsibilities 
  • Practices  safe work habits and adheres to safety procedures and  guidelines. 
  • Participates  on cross functional teams to drive investigation close outs, determine root cause and implement appropriate Corrective and Presentative  Action. 
  • Utilizes  manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive  changes. 
  • Conducts  document revisions and/or document management including batch production records, and manufacturing  procedures. 
  • Works  with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and  compliance. 
  • Performs  training with staff on the floor, as  needed. 
  • Organizes  and participates on cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical  Services. 
  • Works  independently with minimal supervision and  direction. 
  • Participates  in determining objectives of  assignment. 
  • Performs  work that consistently requires independent decision making and exercise of independent judgement and  discretion. 
  • Effectively  utilizes Microsoft office  applications. 
  • Creates  and presents trending and metrics reports.  

* Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs. 

  • Technical  Writing 
  • Deviation  Investigations 
  • Corrective  and Preventative Action  Planning 
  • Document  Change  Requests 
  • Change  Control Execution 

  • High school diploma/GED or Biotech Certification with 5-7 years of experience in  cGXP  manufacturing environment, or bachelor' s degree with 3-5 years of experience. 
  • Demonstrated  knowledge / understanding of biologics  manufacturing. 
  • Knowledge  and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing  operations. 
  • Excellent  written and oral English language skills. 

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Meet Your Recruiter

Marion Bowden

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