Quality Assurance Specialist, Lot Disposition

Adaptimmune

Philadelphia, PA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 03/20/2021
  • Website: adaptimmune.com
  • Company Address: 351 Rouse Boulevard , Philadelphia, PA , 19112

About Adaptimmune

Adaptimmune, a leader in T-cell therapy, is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors, which has the potential to transform the treatment of cancer.

Job Description

Primary Responsibility

The Quality Assurance Specialist will be responsible for supporting quality functions such as line clearance, batch record review, label issuance, raw material release and facilitating timely release of production lots. The successful candidate will work closely with other Quality groups, Quality Control and Manufacturing to identify strategies, tactics and objectives for product quality and GMP compliance.

Key Responsibilities

Conducts record review of executed batch records, QC testing data, and associated batch file documentation to ensure timely disposition of patient lots. 

Performs line/room clearance to support manufacturing activities in aseptic suites

Print and issuance production labels, QC labels and final product labels

Review and release raw materials and consumables for GMP use

Qualifications & Experience

Required

  1. Bachelor’s Degree in a scientific discipline.
  2. Minimum of 5 years in a global biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.
  3. Direct experience with review and approval of batch records and QC testing data
  4. Knowledge of aseptic processing and aseptic gowning techniques
  5. Broad knowledge of GMP, ICH and FDA/EMA regulations
  6. Broad knowledge of Quality Systems, such as Change Control, Investigations, and CAPA
  7. Ability to identify and implement continuous improvement projects as relating to Quality Assurance Operations and the Quality Management System
  8. Demonstrate knowledge of an ability to apply cGMP and quality system regulations
  9. Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities

Desirable

  1. Demonstrated knowledge of document control systems, preferably electronic systems
  2. Ability to work on assigned projects independently with limited supervision.

Skills & Compentencies

Required

  1. Excellent written and verbal skills
  2. Ability to work and communicate internally and externally
  3. Strong attention to detail

Desirable

  1. Able to manage multiple priorities
  2. Excellent problem-solving skills
  3. Able to exercise judgment to determine appropriate corrective actions

 

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.