This role will suit an experienced QC professional with strong technical expertise across analytical testing, laboratory systems, equipment qualification, and GMP compliance within a pharmaceutical or biopharmaceutical environment.
The successful candidate will play a key role in supporting laboratory operations, technical projects, method transfers, investigations, and continuous improvement initiatives while acting as a technical SME within the QC function.
Key Responsibilities
Provide technical support across QC laboratory operations and analytical activities.
Lead and support qualification of analytical equipment and associated testing functions including:
HPLC
Spectrophotometry
Nephelometry
Endotoxin testing
Cell Culture
TOC systems
Coordinate sampling and testing activities during plant and laboratory utility qualification.
Support and coordinate analytical method transfers for new products and processes.
Support raw material, in-process, bulk, utility and finished product testing activities.
Perform and support:
Deviations
Laboratory investigations
OOS investigations
CAPAs
Change Controls
Review and approve QC documentation including protocols, reports, SOPs and work instructions.
Provide SME support and training to laboratory analysts and cross-functional teams.
Support equipment qualification, validation and lifecycle management activities.
Drive laboratory process improvements and Lean initiatives.
Participate in regulatory inspections and support audit readiness activities.
Partner closely with Manufacturing, QA, Engineering and Validation teams to ensure efficient QC operations.
Key Requirements
Bachelor’s Degree in Chemistry, Biochemistry, Microbiology or related scientific discipline.
4–6+ years’ experience within a pharmaceutical or biopharmaceutical QC environment.
Strong technical knowledge of QC analytical methods and laboratory equipment.
Experience working within cGMP-regulated environments.
Strong understanding of:
Deviations
CAPAs
Change Controls
OOS investigations
Data integrity requirements
Experience supporting laboratory investigations and document review activities.
Excellent communication and stakeholder management skills.
Ability to work independently while also collaborating effectively across multifunctional teams.
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