Interim QA Associate
Department: S-MIC Quality
Employment Type: Fixed Term Contract
Location: Stevenage (SMIC)
Reporting To: Jessica Foley
Description
The QA Associate will work within a team to support the operation and performance measurement of the Pharmaceutical Quality System (PQS) across CGT Catapult MICs (Stevenage and Braintree), maintain documentation in all forms, support assessment of quality records, and provide training to personnel in core competencies.
Key Responsibilities
- Perform QA functions within the eQMS (MasterControl / Ideagen) and other GMP computerised systems
- Issue, review, and reconcile controlled documents to CGT Catapult departments and Collaborator organisations
- Maintain QMS and Quality trackers and generate trends and graphs for effective monitoring of the health of the QMS by System Owners and Management
- Engage with quality record owners to support right-first-time and on-time completion.
- Support with Collaborator and external regulatory inspection preparation (e.g. MHRA)
- Review quality documentation such as Non-Conformances, CAPAs, Change Controls, Qualification records and procedure updates
- Support off-site archiving of departmental records (for example: logbooks, forms and reports) • Support for computer system qualification projects as needed.
- Write and deliver training content in QA functions for internal colleagues
- Support the delivery of GMP training to internal colleagues and Collaborator personnel • Provide support to activities across CGT Catapult MICs (Stevenage and Braintree) with periodic travel to the CGT Catapult Braintree facility Experience:
- Experience working in a GMP or Quality Assurance environment
- Experience in the use and operation of an electronic QMS is advantageous
- Experience in Biologics or ATMP, or Sterile manufacturing is advantageous.
Skills, Knowledge and Expertise
- Highly motivated, pragmatic, and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UK
- High-level interpersonal, communication (oral and written) skills and emotional intelligence
- A good team player with a hands-on approach, and adaptable to new challenges
- Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs
- Flexibility towards work assignments and new learning
- Ambitious, collaborative, driven • Accurate, with a strong attention to detail
- A positive attitude towards learning, personal and professional development
- Keeps up to date with industry best practice.
- Willingness to travel • Ambitious, collaborative, driven
- Accurate, with a strong attention to detail
- Planning and time management of tasks to ensure deadlines are consistently met, factoring in the potential of changing circumstances
- Communicates with clarity and conciseness, understanding and adapting the message to engage different audiences
- Retains an engaged and active mind through routine processes/ procedures to remain alert to anomalies or situations requiring further thought/ action
- A positive attitude towards learning, personal and professional development.
