Role Summary
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 Senior QC Scientist I (Operations) is 50% lab based and involves performing any analytical method, ensuring lab compliance, reviewing raw data and result and approval, leading cross functional quality events, troubleshooting, contributing to preparation of validation/tech transfer protocols and reports, leading continuous improvement initiatives and implementation of QC systems, maintaining QC laboratory audit and inspection readiness, supervising laboratory activities, ensuring schedule adherence and data review completeness for batch certification.
Please note, that this is a full-time shift-based role covering either Sunday to Wednesday / Wednesday to Saturday with bi-weekly shift rotation between earlies (6AM - 345PM) and lates (1215PM -10PM).
Key Responsibilities
* Execution of analytical tests - in process drug product samples
* Execution of analytical tests - release drug product samples (all assays)
* Execution of analytical tests - drug product stability samples
* Execution of analytical tests - vector testing
* 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)
* Preparation of User Requirement Specifications for new instruments
* Conducting complex root cause analysis using appropriate tools
* Initiation of deviation, laboratory investigation, change control or CAPA as required
* Performing impact assessment for major deviations and major change controls
* Leading internal QC investigations forming part of deviation, laboratory investigation
* Defining and implementing effective CAPA within QC and across multiple functions
* Ownership of major internal QC change controls
* Acting as SME in change control process
* Performing risk assessments for internal QC procedures and processes
* Data entry / collation for tracking and trending purposes
* Review and approval of QC records
* Preparation of calculating spreadsheets following guidelines
* Design of data trending / tracking approaches
* 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 and analytical methods)
* Preparation / review of certificate of analysis
* Review and approval of SOPs / spreadsheets
* When required acting as shift supervisor
* Managing batch certification activities
* Implementation of QC processes / systems
* Approval of certificates of analysis
* Execution of tech transfer, validation / verification of analytical methods
* Preparation of tech transfer / validation / verification protocols
* Participation in preparation of tech transfer, validation / verification reports
* 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
* Minimum 8 years' experience within a QC laboratory, without a BSc/MSc degree or
* Minimum 5 years’ experience within a QC laboratory, with a BSc/MSC degree or
* Minimum 2 years' experience within a QC laboratory, with a PhD in life sciences or relevant subject
Qualifications
* BSc/MSc degree in life sciences (P) or significant relevant industry experience
Skills/Specialist knowledge
* Soft skills (effective written and spoken communication, organisation, teamwork) (E)
* Ability to precisely follow instructions and procedures (E)
* Open to working shifts (E)
* Attention to detail (E)
* Meet requirements to work in cleanroom environment (E)
* Expert technical writing and data presentation skills using multiple tools (e.g., Office 365, GraphPad Prism) (P)
* Ability to prepare complex calculating spreadsheets, large documents and presentations (E)
* Understanding of biostatistics applied in Quality Control (e.g., parallelism, relative potency, regression analysis) (E)
* Reporting of numerical values – significant figures, decimal places, rounding in the context of generating and reporting results (E)
* Understanding of method performance parameters (e.g., precision, accuracy, linearity, range, LOQ, LOD) (E)
* Working knowledge of analytical method lifecycle, validation, tech transfer designs (E)
* Working knowledge of relevant regulations governing Quality Control function (e.g., EudraLex, ICH, FDA CFR) (P)
* Working knowledge of Quality Management System records (e.g., deviation, CAPA, laboratory investigation, change control) (E)
* Expert knowledge of aseptic technique and cell culture methodology (E)
* SME knowledge in complex analytical instruments (e.g., ddPCR, qPCR, flow cytometer) (P)
* Familiarity with relevant sections of regulatory dossier (E)
* Technical expertise at least one of the assay platforms (cell based or molecular) SME level during internal audits (E)
* Understanding of stability / shelf-life management for pharmaceutical products (P)
* Experience in LIMS (P)
* Experience of training, mentoring and supervision of junior laboratory staff (E)
* Experience leading cross-functional projects (P)
* Technical expertise of analytical aspects of analytics of biologics
* Working knowledge of biostatistics/Trend (P)
* Good level of understanding of GMP quality system (e.g., deviations, OOX, invalid assays)
* Minimum of 3 years’ experience in a GMP laboratory (E)
* Experience in leading investigations for OOS / QERs / Change controls (E)
* Experience in authoring GxP documentation (E)
* Technical Expert in at least one of the following and understanding knowledge of:
* Manufacturing process:
o Good understanding the manufacturing process (QC and production elements) based on product specification file and regulatory filings (IND, IMPD)
* Assay knowledge:
* Understand and be able to explain:
o The principle of the assays – all assays for drug product / vector / plasmids and other critical components of the manufacturing process
o In depth understanding of technology platforms used in Quality control (internal Autolus)
o System / sample acceptance criteria (where applicable) - all internal / external drug product assays
* QC instrumentation:
* Data analysis skills:
o Statistical analyses – data plotting, data evaluation using TOST (equivalence), regression analysis, control chart design and interpretation
o Data collation, visualization, comparisons
o Analytical method validation / tech transfer
* Understand and be able to explain:
o High level of familiarity with regulatory guidelines around technology transfer and validation (e.g., ICH, USP)
o Stability and shelf life
* Understand and be able to explain:
o How shelf life is determined
o How stability is determined
o Requirements for stability protocol
o Conduct of stability studies for drug product / vector
* Proficient user of Office 365 tools including Visio, PowerPoint, Excel, Word, Graph Pad Prism
* Excellent understanding of GMP regulations