Job Description
Contract – 6 Months contract with a possibility of extension
Job Description:
The QC Chemist will support all technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, and documentation completion and review in full compliance with GMP regulations, procedures, and product specifications.
Key Responsibilities:
- Compendia experience (USP, EP, BP, JP, CP).
- Finished Product testing, Environmental Monitoring, Sterility QC testing, and reporting of the QC results.
- Escalation in case of non-conformances and deviations, and manage these quality incidents as per procedures.
- Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow-up and implementation, and Change Control management, including procedure and form revisions.
- Participation in assigned qualification/validation activities, as necessary.
- Responsible for the successful on-time completion of required training curricula comprising the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other relevant training, including HSE for the specific role.
- Prepares applicable documents, forms, and records such as analytical batch records, and follows Good Documentation Practices. Support internal and external Audits and Inspections, as required.
Essential Requirements:
- Education: Bachelor's degree required in a relevant Scientific discipline (e.g, Chemistry, Microbiology).
- A minimum of 2-3 years of experience in a cGMP or aseptic environment is required. Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, as well as Aseptic techniques.
- Practical experience with Microbiology method verification and routine testing practices, EM Monitoring, and basic knowledge of method/equipment validation principles and methodologies preferred; HPLC knowledge is required.
- Ability to interpret analytical data and convert it into technical documentation.
- Basic knowledge and understanding of aseptic principles and techniques, Quality Control Sampling, Quality Control (QC Testing), and General HSE knowledge.