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 of Associate QC Scientist (Operations) is 90% lab based and involves performing in process analytical methods and reviewing data, equipment maintenance, laboratory housekeeping.
Please note this is a shift-based role working Wednesday to Saturday, with bi-weekly rotations of shift hours. The shift patterns include early shifts from 06:00 AM to 3:45 PM, mid shifts from 08:00 AM to 5:45 PM, and late shifts from 12:15 PM to 10:00 PM.
Key Responsibilities
- 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., 5-why'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
Demonstrated skills and competencies
E – Essential
P – Preferred
Experience
- BSc/MSc degree in life sciences (P)
- 1 year experience in QC laboratory without BSc/MSc degree in life sciences
Qualifications
- BSc/MSc degree in life sciences or significant relevant industry experience
Behaviours
- Attention to detail (E)
- Ability to precisely follow instructions & procedures (E)
- Ability to make quality-critical decisions (E)
- Good communication, organisation, teamwork (E)
- Curious to learn with a can-do attitude (E)