LSNE Contract Manufacturing

JOB SUMMARY
Review all records associated with the manufacturing of a product lot for completeness and accuracy to ensure qualified specifications, parameters, and controls have been met and/or all deviations from such have been adequately and timely addressed.

JOB DUTIES

  • Complete Executed Batch Record/protocol Review and supporting documentation with minimal to no supervision:

    • Minor Deviations & supporting documentation
    • Quality Control records
    • Environmental Monitoring data
    • CAPA documents and QA investigations
    • Cleaning / Sterilization cycle records and testing
  • Review protocol, study design and Master batch Records with direct to minimal supervision based on complexity
  • Responsible for writing and revising Standard Operating Procedures, material control procedures, deviations, CAPA's, and Quality Investigations when applicable under direct to limited supervision
  • Create / Revise documents using MS Office
  • Review/approve minor system SOP updates
  • Retrieve GMP Records upon request
  • Assist and/or confirm with Line Clearance
  • May represent QA in cross functional teams to improve SOPs and systems
  • Complete AQL Sampling and Inspection of Final Package Lots as applicable
  • Obtain gown certification for aseptic operations if position is at aseptic facility
  • Other duties as assigned 

PREPARATION, TRAINING & EXPERIENCE

EDUCATION, EXPERIENCE, QUALIFICATIONS

  • Exceptional organizational skills
  • Detail oriented
  • Ability to multi-task
  • Word Processing, XL spreadsheets, SOP generation
  • Competent in MS Office 
  • Professional verbal and written communication skills required
  • High School diploma with 10+ years' experience in GMP QA environment; Bachelor of Science Degree preferred with 5-10 years (Masters degree + 1-5 years) in QA in a cGMP environment
LSNE Contract Manufacturing
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

    I agree to ApplicantPro's Applicant Information Use Policy.*
  • Sign Up For Job Alerts!

  • Share This Page
  • Facebook Twitter LinkedIn Email
.
logo Services Facilities About Us News & Events Careers Contact Us Linked In