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- Tasks: Lead quality control testing and ensure compliance in a dynamic lab environment.
- Company: Join a cutting-edge pharmaceutical company focused on innovative drug development.
- Benefits: Enjoy shift flexibility, competitive pay, and opportunities for professional growth.
- Why this job: Be part of a mission-driven team that impacts patient lives through quality assurance.
- Qualifications: 8+ years in QC or relevant degree; strong analytical and communication skills required.
- Other info: Full-time role with rotating shifts; must be open to working in a cleanroom.
The predicted salary is between 48000 - 72000 £ per year.
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Senior QC Scientist, QC Operations, Hertfordshire
Client:
Location: Hertfordshire, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
ae9a8304b7a9
Job Views:
88
Posted:
03.03.2025
Job Description:
Role Summary
Quality Control Operations manages and executes all routine testing using validated analytical methods and following prescribed testing plans. Test results allow monitoring and driving the manufacturing processes, releasing the product or material, determining the shelf life of the product or material, and assessing 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 results, approving, 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 – 3:45PM) and lates (12:15PM – 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 with 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
- 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
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)
- 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:
- Good understanding of 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:
- The principle of the assays – all assays for drug product / vector / plasmids and other critical components of the manufacturing process
- In depth understanding of technology platforms used in Quality control (internal Autolus)
- System / sample acceptance criteria (where applicable) – all internal / external drug product assays
- QC instrumentation:
- Data analysis skills:
- Statistical analyses – data plotting, data evaluation using TOST (equivalence), regression analysis, control chart design and interpretation
- Data collation, visualization, comparisons
- Analytical method validation / tech transfer
- Understand and be able to explain:
- High level of familiarity with regulatory guidelines around technology transfer and validation (e.g., ICH, USP)
- Stability and shelf life
- Understand and be able to explain:
- How shelf life is determined
- How stability is determined
- Requirements for stability protocol
- 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
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Senior QC Scientist, QC Operations, Hertfordshire employer: TN United Kingdom
Contact Detail:
TN United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QC Scientist, QC Operations, Hertfordshire
✨Tip Number 1
Familiarize yourself with the specific analytical methods and technologies mentioned in the job description, such as ddPCR and qPCR. Being able to discuss your hands-on experience with these techniques during the interview will demonstrate your expertise and fit for the role.
✨Tip Number 2
Highlight your experience in maintaining compliance with GMP regulations. Prepare examples of how you've ensured laboratory readiness for inspections and audits, as this is a key responsibility in the Senior QC Scientist role.
✨Tip Number 3
Showcase your leadership skills by discussing any experience you have in mentoring or supervising junior staff. This will be important as the role involves managing laboratory activities and ensuring adherence to schedules.
✨Tip Number 4
Be prepared to discuss your experience with cross-functional projects and how you've contributed to continuous improvement initiatives. This aligns with the responsibilities of leading quality events and implementing QC systems.
We think you need these skills to ace Senior QC Scientist, QC Operations, Hertfordshire
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Control laboratories. Emphasize your analytical skills, technical writing abilities, and any specific instruments or methodologies you have worked with.
Craft a Strong Cover Letter: In your cover letter, express your passion for quality control and how your background aligns with the responsibilities of the Senior QC Scientist role. Mention specific experiences that demonstrate your ability to lead investigations and manage QC processes.
Highlight Relevant Skills: Clearly outline your soft skills such as communication, teamwork, and organization. Also, emphasize your technical expertise in analytical methods and your understanding of GMP regulations, as these are crucial for the role.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no grammatical errors and that all information is presented clearly and professionally, reflecting your attention to detail.
How to prepare for a job interview at TN United Kingdom
✨Showcase Your Experience
Make sure to highlight your relevant experience in a QC laboratory, especially if you have over 8 years of experience or a PhD. Be prepared to discuss specific analytical methods you've worked with and how they relate to the role.
✨Demonstrate Technical Knowledge
Familiarize yourself with the key technical aspects mentioned in the job description, such as method performance parameters and biostatistics. Be ready to explain your understanding of these concepts during the interview.
✨Prepare for Behavioral Questions
Expect questions about teamwork, communication, and problem-solving. Use the STAR method (Situation, Task, Action, Result) to structure your responses and provide concrete examples from your past experiences.
✨Understand Regulatory Guidelines
Brush up on relevant regulations governing Quality Control functions, such as EudraLex and ICH guidelines. Being able to discuss these regulations will demonstrate your expertise and readiness for the role.
