Batch Record Specialist

Company: Cambrex
Location: Charles City
Posted on: May 26, 2023

Job Description:

Company Information




You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• 
  
• engage in work that matters to our customers and the patients they serve
  
• learn new skills and enjoy new experiences in an engaging and safe environment
  
• strengthen connections with coworkers and the community
  
  We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more! -
  Your Future Matters.
  Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
  Job Overview
  
  
  The Batch Record Specialist is responsible for working with the Process Engineers and other Operations personnel to develop or revise process documentation in a timely manner.
  Responsibilities
  
  
  
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  • Writing batch records and cleaning batch records, campaign reports and other miscellaneous reports and documents as needed
    
  • Working with the appropriate departments to set up process codes, label requests and MSDS revisions
    
  • Develop and maintain Standard Operating Procedures
    
  • Developing and maintaining IQ OQ and PQ documents and protocols
    
  • Develop - and maintain any document templates such as batch records, protocols as needed
    
    All employees are required to adhere to DEA, EPA, FDA, OSHA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. - All employees are expected to report to work regularly and promptly. - Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
    Education, Experience & Licensing Requirements
    
    
    
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    • Bachelor's degree in Chemical Engineering required. -
      
    • 2 or more years of experience in an office environment is preferred.
      
    • Strong organizational and communication skills.
      
    • Proficient in windows based environment including word processing, spreadsheet and data base programs.
      
      
      Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
      
      Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program.' -
      -
      #CB
      #LI-JG1

Keywords: Cambrex, Rochester , Batch Record Specialist, Other , Charles City, Minnesota