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Quality Assurance Specialist, Lot Release (second shift)

SUMMARY

The Quality Assurance Specialist will provide support for all drug product lots manufactured for Adaptimmune LLC and be responsible for ensuring the timely release of manufactured patient lots. The individual will be responsible for reviewing master batch records, QC testing, and patient specific documentation. The individual will be responsible for issuing batch labels and performing line clearance activities inside the clean room suites. In addition, the individual will also help with review of deviations and CAPAs associated with lot release activities. The successful candidate will work closely with Quality Management, Manufacturing and Contract Organizations to identify strategies, tactics and objectives for product quality and GMP compliance.

 

KEY RESPONSIBILITIES

  • Conducts review of executed master batch records and ensures drug product meets acceptable quality attributes for release.
  • Perform on the floor audits, line clearance activities and issuance of batch labels.
  • Opens deviations and investigations as appropriate based on Adaptimmune CMC and/or CMO notification; provides evidence of document closing at time of product disposition.
  • Assures all Quality events, change controls, CAPAs and/or other required documentation related to the product lots are completed and closed prior to material/lot release.
  • Support the release of incoming raw material to ensure material meet specification prior to release for use in GMP manufacturing.
  • Works with CMOS/CTLs to ensure timely delivery of documentation/materials.
  • Evaluates analytical results against approved specifications to determine compliance; releases material for use and/or provides an appropriate disposition for products.
  • Develops process/procedures for release in conjunction with CMC personnel.
  • Evaluates environmental monitoring results for conformance with ICH requirements in support of lot release.
  • Evaluates lot test results against trending data to identify any irregular behaviour.

 

QUALIFICATIONS & EXPERIENCE

  • Bachelor’s Degree in a scientific discipline.
  • Minimum of 2-4 years in a global biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.
  • Solid technical writing skills related to investigation reports.
  • Broad knowledge of GMP, ICH and FDA/EMA regulations
  • Broad knowledge of Quality Systems, such as Change Control, Investigations, and CAPA
  • Excellent writer including but not limited to SOPs and reports
  • Demonstrated knowledge of document control systems, preferably electronic systems
  • Previous aseptic gowning training
  • Excellent written and verbal skills
  • Ability to work and communicate internally and externally
  • Strong attention to detail
  • Able to manage multiple priorities
  • Excellent problem-solving skills
  • Able to exercise judgment to determine appropriate corrective actions

                                               

                                                               

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