Senior Quality Assurance Specialist

6 days ago

Philadelphia, Pennsylvania, United States Adaptimmune Full time
Job Title: Sr. Quality Assurance Specialist

Adaptimmune is a leading biotechnology company with a strong presence in the UK and US. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.

Our company culture is built on trust, inclusion, collaboration, and a commitment to honesty and bravery in our pursuit of transforming the lives of people with cancer.

The Sr. Quality Assurance Specialist will play a critical role in supporting quality functions such as line clearance, batch record review, label issuance, raw material release, and facilitating timely release of production lots. This position 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.
  • Prints and issues production labels, QC labels, and final product labels.
  • Reviews and releases raw materials and consumables for GMP use.

Qualifications & Experience:

  • Bachelor's Degree in a scientific discipline.
  • Minimum of 5 years in a global biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.
  • Direct experience with review and approval of batch records and QC testing data.
  • Knowledge of aseptic processing and aseptic gowning techniques.
  • Broad knowledge of GMP, ICH, and FDA/EMA regulations.
  • Broad knowledge of Quality Systems, such as Change Control, Investigations, and CAPA.
  • Ability to identify and implement continuous improvement projects as relating to Quality Assurance Operations and the Quality Management System.
  • Demonstrate knowledge of an ability to apply cGMP and quality system regulations.
  • 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:

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

Adaptimmune is an equal opportunities employer and welcomes applications from all qualified candidates, regardless of age, color, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status, or other legally protected category.

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