Senior Aseptic Services Technician – Education and Training | The Christie NHS Foundation Trust in Manchester

There has never been a more exciting and innovative time to work for our Aseptic services team. An excellent opportunity has become available for a Pharmacy or Science Manufacturing Technician with experience and interest in Aseptic Services to become a member of our team. The Aseptic Services Unit at the Christie NHS Trust is a world leader in the production of phase one clinical trial materials. We prepare an extensive portfolio of hundreds of Clinical Trials alongside Early Access Medicines, Free of Charge products and Compassionate use schemes.

The suitable applicant should be highly motivated and show accurate attention to detail. They should be organised and able to prioritise work effectively showing excellent interpersonal and communication skills. The successful candidate will become part of our dynamic and fast paced team who are truly dedicated to creating products that help treat patients with cancer. They will participate in and supervise the Aseptic production of Clinical trials, SACT, EAMS, FOC and Gene therapy injectable medicines in one of our dedicated cleanrooms housing a total five negative pressure isolators. They will be responsible for supporting the Education and Training Lead in Aseptic Services in the initial and re-validation training of the team, as well as the day to day running of the unlicensed production unit, managing staff, stock, HR duties and Quality Assurance.

Responsibilities

• Supervision and management of technical staff, including HR duties (e.g. PDRs)
• Organising the safe and efficient production of aseptically prepared products
• Delivering full training to production staff taking part in GMP activities, ensuring proficient and safe working within an Aseptic Services Unit
• Supporting co-ordination of operator validations and competency checks
• Co-ordinating workflow and workforce, ensuring a safe, efficient and effective service to the trust and patients
• Revision of Standard Operating Procedures and implementation of new or revised procedures
• Managing cost effective use of consumables and sanitisation products used within the aseptic facility
• Taking part in internal and external audits
• Supporting investigations related to events in production, carrying out Quality Assurance tasks

The Aseptic team is a diverse and dynamic team who work in a specialised cleanroom environment where teamwork is the key to efficiency and managing the patient experience. Each day is both challenging and rewarding in equal measures, with cancer treatments constantly evolving and new types of drugs being trialled each year. We are at the forefront of developments in terms of drug innovation and team development. We were one of the first hospitals in the country to introduce the progression role of Aseptic Practitioner to pharmacy, and we currently offer the Science Manufacturing Technician qualification as part of our already large portfolio of training and staff qualifications here at The Christie NHS Foundation Trust. The Pharmacy department has a developed career pathway for technical staff wishing to progress as far as achievable. Helping support all qualifications and in-house training that allow for this progression should you wish to further your career within the pharmacy aseptic team.

So, if you want to work as part of an ever-progressing team and you enjoy a challenge then we are the team for you.

Duties and Responsibilities

• Promotes team working within the Aseptic Services team.
• Keeps team informed of changes throughout preparation sessions.
• Is self-motivated and committed as a team leader, promoting staff development and supporting all levels of staff working in accordance with local SOPs and guidelines.
• Ensures that essential information is communicated effectively to all aseptic staff, customers, MDTs and to other pharmacy staff in a timely manner.
• Acts as a professional role model, develops positive relationships with key personnel both internally and externally to the department.
• Keeps ASM, Deputy ASM, Chief Technician and Highly Specialised Technician up to date with changes which may affect capacity or cause delays in workload.
• Liaises with wards and departments regularly to ensure patients treatments are provided in a timely manner when treatment is taken off hold.
• Gives achievable ETA to ward staff as when treatment will be ready to collect.

Analytical and Judgmental Skills

• Is aware of alert and action limits for environmental monitoring and subsequent measures needed to rectify issues in line with SOPs and policies.
• Performs accuracy checks on documentation, including worksheets and labels which may contain complex calculations.
• Ensures the completion of all logs and records and informs Authorized Pharmacist, ASM, Deputy ASM, Chief Technician or Highly Specialised Technician of any results which either show significant changes or are outside the specified limits.
• Performs in-process accuracy checks during cleanroom supervision sessions as required.
• Reviews SOPs and worksheets and assist in implementation of any new/changed procedures.

Planning and Organisational Skills

• Is responsible for the planning of workload schedules, informing the Highly Specialised Technician of any discrepancies or issues as they arise.
• Assists the Highly Specialised Technician in planning, organising and managing the workload in accordance with the capacity plan, ensuring adequate numbers of appropriately trained staff are available to perform tasks required for a given activity level and feeding back information to managers when breaches and constraints occur.
• Ensures adherence to environmental monitoring schedules in accordance with departmental procedures.
• Ensures that an efficient aseptic dispensing and distribution service is provided to patients and staff which is in line with current standards and conforms to agreed service deadlines within the service level.
• Is responsible for ensuring Aseptic Services administrative duties are carried out appropriately by technical staff including the filing and archiving of information and data.
• Complies with all legal requirements relating to the prescribing, dispensing and storage of pharmaceutical products and works to the relevant standard operating procedures at all times and in accordance with criteria set out under COSHH regulations.

Physical Skills

• Participates in the production of all types of aseptically prepared products demonstrating the necessary high standard of dexterity, accuracy and precision required for aseptic manipulations and long periods of concentration performing accuracy checks.

Responsibility for Patient Care

• Maintains compliance with Rules and Guidance to Good Manufacturing Practice and any other local, regional and national guidance documents.
• Assists with the maintaining Quality Assurance Standards in accordance with National, Regional and local requirements.
• Participates in ensuring that the aseptic service complies with clinical governance strategies, including risk management assessments of working practices, reporting of clinical incidents, pharmacy error reporting schemes, intervention monitoring and risk reduction strategies.
• Conducts regular documented GMP Observations, referring to Highly Specialised Technician, Chief Technician and ASM/Deputy ASM where non-compliance or deviation identified.
• Is trained and named on the intrathecal register to undertake appropriate preparation and documentation tasks relating to intrathecal chemotherapy services following local, trust and national guidance for the safe administration of intrathecal chemotherapy.
• It will be a requirement of the post holder to participate in the Aseptic On-Call preparation service for chemotherapy outside normal working hours on a rotational basis.
• To participate in a Saturday/Sunday and Bank Holiday rota, when the service requires which may be on a regular/rota basis.
• Undertakes any other duties of a similar nature requested by the ASM, Deputy ASM, or the Director of Pharmacy.

Responsibility for Policy/Service Development

• Assists in audits and produces written reports and provides statistical information with identified action.
• Assists in the validation, performance reviews of equipment and processes used in Aseptic Services, ensuring that they continually achieve their intended purpose in the allocated area.
• Establishes and enforces effective communication systems to ensure pharmacy staff are kept informed of all technical operations in line with the change control process.

Responsibilities for Financial and Physical Resources

• Ensures the completion of workload statistics as required.
• Assists in the management of procurement of medicines, equipment and consumables and the stock control within the unit.
• Ensures patients receive drug products as required for administration.
• Receives, checks and reconciles goods received with orders placed/delivery notes.
• Enters details of goods received onto delivery notes/computer system.
• Transfers goods to correct stock location and rotates stock to ensure that shorter dated stock is used first to avoid unnecessary wastage.
• Complies with legal and trust requirements relating to the purchase, supply, use, safe custody and destruction of medicines within Pharmacy and other areas of the Trust.
• Ensures that all items used in aseptic and dispensing procedures are recorded as costed issues through the Drug Management and Administration software systems.
• Assesses pharmaceutical products returned from clinical areas.
• Returns to stock items which are fit for reuse or disposes of items unfit for use, in accordance with COSHH regulations and Trust procedures.
• Processes the returns following departmental procedures.
• Carries out regular stock checks within the department in accordance with local procedures to ensure computer records accurately reflect stock holding.
• Performs investigations when stock deviations are identified to rectify and document actions.
• Identifies and reports stock discrepancies to ensure that pharmaceutical products are available for patients when required and waste is minimised.
• Monitors cold storage equipment to ensure temperatures are within the defined limits and reports any variation to a Highly Specialised Technician.
• Maintains storage areas in an organised, safe and tidy condition in accordance with Health and Safety regulations.
• Participates in a system for checking expiry dates of stock.
• Ensures that stock is rotated so that shorter dated stock is used first to avoid unnecessary wastage.
• Removes out of date stocks informing Highly Specialised Technician and where appropriate, disposes of the stock, recording the issue on the pharmacy computer.
• Ensures high-cost drugs are accurately stocked and maintained.
• Performs weekly checks, investigating, rectifying, and reporting any deficiencies.

Responsibilities for Human Resources

• Supervises Band 4 technicians, aseptic practitioners and assistant groups within the aseptic suite to ensure compliance with Good Manufacturing Practice and departmental procedures and protocols.
• Participates in the recruitment process for Band 4 technicians, aseptic practitioners and assistants.
• Performs appraisals with junior members of the team as delegated.

Responsibility for Information Resources

• Can navigate pharmacy systems used for prescribing, dispensing, ordering and receipt.
• Ensures completion of records, worksheets and logs including patient data following ALCOA principles, adhering to data integrity standards.
• Accurately transcribes prescription details to generate worksheets and labels for Aseptically prepared products in line with national, regional and local guidance.
• Assists in ensuring that systems are in place for the accurate and effective management of the Aseptic Services computer system to record all issues, receipts and returns.
• Reports and participates in the collation of near miss and error data.
• Participates in the collation of activity data.

Responsibilities for Research and Development

• Participates in the aseptic services audit/validation calendar.
• Contributes to the remedial action plan in response to audits and to the delivery of these plans.
• Pro-actively identifies and initiates improvements and developments to working practices, procedures and documentation.
• Participates in aseptic preparation of clinical trials.
• Assists in audits and produces written reports and provide statistical information with identified action.

Freedom to Act

• Deputises for the Highly Specialised Technician in their absence.
• Deals with initial complaints, investigations and referring to managers as required.
• Completes appropriate incident reports liaising with Highly Specialised Technician, Chief Technician and ASM/Deputy ASM. In the case of equipment/air handling failure, take immediate appropriate action then report to senior staff.
• Keeps updated with current pharmaceutical practice and knowledge, attending approved meetings, courses or conferences relating to role necessary for personal and departmental development. Recording these as CPD Entries.
• Maintains annual professional registration.