Associate Qc Scientist - Stevenage, United Kingdom - Autolus Ltd

Autolus Ltd

Verified Company

Stevenage, United Kingdom

1 week ago

Posted by:

Tom O´Connor

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Description

We are currently looking for an Associate QC Scientist or QC Scientist to join our Bioassay QC Team based at our Cell Manufacturing site in Stevenage.

Quality Control Operations manages and executes all routine testing using validated analytical methods and following prescribed testing plans.

Test results allow to monitor and drive the manufacturing processes, release the product or material, determine shelf life of the product or material and assess potency, quantity, identity and safety against defined specifications.

The role is working on our Wednesday to Saturday shift team. The working hours rotate every 2 weeks between earlies (6am to 3.45pm) & lates (12.15pm to 10pm).

The role of Associate QC Scientist (Operations) is 90% lab based and involves performing in process analytical methods and reviewing data, equipment maintenance, laboratory housekeeping.

Some of the duties at this level include:

Execution of analytical tests in process drug product samples
Laboratory housekeeping maintenance of laboratory in inspection ready state
Reagent preparation (e.g., preparation of media, aliquots, controls)
Management of QC materials (e.g., media preparation, aliquoting, stock management)
Operation and maintenance of analytical instruments in accordance to governing SOPs
Conducting basic root cause analysis (e.g., 5why's)
Initiation of deviation, laboratory investigation as required
Performing impact assessment for minor deviations
Data entry / collation for tracking and trending purposes
Archiving of GMP records
Completion of GMP documentation in accordance with ALCOA/data integrity requirements
Designing GMP documentation (e.g., logbooks, forms)
Managing GMP documentation (logbooks, worksheets, documentation trackers)
Timely completion of own quality events
Any other duties as required following consultation with the post holder
Work in adherence to local Health and Safety policies and SOPs

The role of QC scientist (Operations) is 70% lab based and involves performing in process and release testing, leading minor quality events, identifying and implementing continuous improvement initiatives, executing validation/tech transfer protocols.

Some of the duties at this level include:

Execution of analytical tests in process drug product samples

Execution of analytical tests release drug product samples (selected assays).
Execution of analytical tests drug product stability samples.
Laboratory housekeeping maintenance of laboratory in inspection ready state

Reagent preparation (e.g., preparation of media, aliquots, controls)

Management of QC materials (e.g., media preparation, aliquoting, stock management)

Operation and maintenance of analytical instruments in accordance to governing SOPs

Participation in execution of qualification scripts (IOPQ).
Conducting root cause analysis using appropriate tools.
Initiation of deviation, laboratory investigation, change control or CAPA as required.
Performing impact assessment for minor deviations

and minor change controls.

Leading internal QC investigations forming part of deviation, laboratory investigation.
Defining and implementing effective CAPA within QC.
Ownership of minor internal QC change controls.
Data entry / collation for tracking and trending purposes

Review of QC records.
Preparation of calculating spreadsheets following guidelines.
Archiving of GMP records

Completion of GMP documentation in accordance with ALCOA/data integrity requirements

Designing GMP documentation (e.g., logbooks, forms)

Managing GMP documentation (logbooks, worksheets, documentation trackers)

Timely completion of own quality events

Designing worksheets.
Preparation of high quality SOPs using approved templates (general QC procedures).
Preparation of certificate of analysis.
Participation in tech transfer, validation / verification of analytical methods.