Senior QC Scientist, QC Operations

ZipRecruiter; Stevenage; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the pharmaceutical sector seeks a Quality Assurance professional to oversee analytical testing and ensure compliance with GMP standards. The ideal candidate will have significant experience in quality assurance within the pharmaceutical industry, with a strong understanding of GMP and GCP principles. This role involves managing QC materials, executing analytical tests, and leading internal investigations, ensuring the highest standards of quality and safety are maintained.

Qualifications

• 2-5 years’ industrial experience in quality assurance.
• Experience with MHRA and HTA inspections.

Responsibilities

• Execution of analytical tests on drug product samples.
• Management of QC materials and laboratory housekeeping.
• Preparation and review of certificates of analysis.

Skills

GMP & GCP principles

Good communication skills

Teamwork

Accountability

Education

BSc in pharmaceutical sciences

MSc in pharmaceutical sciences

Job description

Job Description

This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the + business community. Please do not contact the recruiter directly.

Key Responsibilities

• Execution of analytical tests on in-process drug product samples
• Execution of analytical tests for drug product release samples (all assays)
• Execution of analytical tests on drug product stability samples
• Execution of analytical tests for vector testing
• Laboratory housekeeping to maintain inspection-ready state
• Reagent preparation (e.g., media, aliquots, controls)
• Management of QC materials (media preparation, aliquoting, stock management)
• Operation and maintenance of analytical instruments following SOPs
• Participation in executing qualification scripts (IOPQ)
• Preparation of User Requirement Specifications for new instruments
• Conducting root cause analysis using appropriate tools
• Initiating deviations, laboratory investigations, change controls, or CAPAs as needed
• Performing impact assessments for major deviations and change controls
• Leading internal QC investigations related to deviations and laboratory issues
• Defining and implementing effective CAPA within QC and other functions
• Owning major internal QC change controls
• Acting as SME in change control processes
• Performing risk assessments for QC procedures and processes
• Data entry and collation for tracking and trending
• Review and approval of QC records
• Preparation of spreadsheets following guidelines
• Designing data trending and tracking approaches
• Archiving GMP records
• Completing GMP documentation per ALCOA/data integrity standards
• Designing GMP documentation (logbooks, forms)
• Managing GMP documentation (logbooks, worksheets, trackers)
• Timely completion of own quality events
• Designing worksheets
• Preparing high-quality SOPs using templates (general QC procedures and methods)
• Preparation and review of certificates of analysis
• Review and approval of SOPs and spreadsheets
• Acting as shift supervisor when required
• Managing batch certification activities
• Implementing QC processes and systems
• Approval of certificates of analysis
• Executing tech transfer, validation, and verification of analytical methods
• Preparing protocols for tech transfer, validation, and verification
• Participating in the preparation of related reports
• Performing other duties as required in consultation with the post holder
• Adhering to local Health and Safety policies and SOPs

Demonstrated Skills and Competencies

E – Essential
Experience:

• 2-5 years’ industrial experience in roles responsible for quality assurance in pharmaceutical or similar systems
• Experience with MHRA (E) and HTA (P) inspections, either as host or involved contractor

Qualifications:

• BSc in pharmaceutical sciences, immunology, or equivalent (E)
• MSc in pharmaceutical sciences, immunology, or equivalent (P)

Skills/Specialist Knowledge:

• GMP & GCP principles
• Manufacturing and testing procedures for advanced therapies
• CAR T-cell technology fundamentals
• Good communication skills and ability to motivate colleagues
• Ability to build cross-departmental relationships
• Teamwork, responsibility, and accountability
• Ability to work independently to high standards with minimal supervision