QC Analyst Raw Materials At GSK
Job Purpose
The QC Raw Material Specialist is a position for the QC Raw Material and Compendial Laboratory within the Quality Organization. This specialist reports directory to the QC Compendial Manager. The QC Raw Material Specialist is a subject matter expert for Biopharm Raw Materials, oversees technical transfers of Raw Materials, and manages the raw material specifications.
Key Responsibilities:
Develops and/or authors raw material testing methods, procedures, and specifications in compliance with all regulations (domestic and international), cGMP’s, cGLP’s, and corporate requirements.
Assess vendor changes as related to raw materials/ raw material testing.
Assesses and implements compendial changes and provides Subject Matter Expertise in all applicable pharmocoepia related to raw material testing – USP/NF, EP, JP, ChP, BP, etc.
Reviews, evaluates, and manages initiatives to improve Quality Operations overall laboratory operational efficiency and GMP performance.
Manages raw material analytical technical transfers and method validation/ verification timelines and resourcing via R&D and Third Parties.
Responsible for the control and timely disposition of raw materials used for method qualification.
Oversight of external laboratory testing and spend.
Provide subject matter expertise and/or assistance in the investigations of all related deviations/investigations as related to raw materials.
Participates in inspections/audits (regulatory and internal) and may author/review raw material sections of regulatory filings as needed
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
B.S. or Masters Degree in Chemistry or related science.
6 months of experience and understanding of analytical testing methodology.
Area of specialisation in Biochemistry or Chemistry.
Ability to work with peers in R&D and 3rd party clients.
Ability to evaluate chemical methods for comparability.
Ability to effectively manage workload.
Demonstrated leadership skills.
Solid team player able to function within team based organisation in multi-disciplinary environment including R&D, MSAT, Supply Chain Operations, and QA.
Strong verbal and written communication skills.
Able to influence without authority.
Able to prioritise and decide appropriate course of actions. Effective at implementing decision.
Fully versed in GMP’s, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical functions.
Job Posting End Date: 11 December 2023