General information
Company / Establishment
SEQENS is an integrated global leader in pharmaceutical solutions and specialty ingredients, delivering outstanding performance, unrivalled market responsiveness and tailor-made solutions to our customers.
Our mission is to bring R&D and industrial performance to our clients' projects with our unique skill set and a broad range of technologies.
SEQENS operates 24 manufacturing plants and 10 R&D centers in Europe, North America and Asia with 3,200 employees. More than 300 scientists, engineers and experts develop tailor-made solutions for our customers and ensure that products are successfully transferred into production.
Reference
2023-1117
Position description
Job Family / Sub-family
Quality & Regulatory - Quality Control
Contract type
Permanent
Job title
Sr. Analyst/Analyst II, Quality Control M/F/D
Position Context:
Proactively perform QC function in full compliance with cGMP
Main tasks :
· Proactively perform QC function in full compliance with cGMP.
· Oversee / conduct the transfer of validated methods from Method Development group to Quality Control laboratory.
· Performing analyses using qualified/validated analytical methods for raw materials, IPC, final product, stability study, and cleanout samples, for API, and non-API products all under cGMP.
· Keep good lab record and maintain GMP documentation.
· Schedule workflow and supervise other QC Analysts.
· Oversee and lend support to laboratory personnel in testing raw materials, in-process samples, finished product, and stability samples.
· Troubleshoot, maintain, procure and install various analytical instruments.
· Actively participate on cross functional improvement initiatives.
· Conduct lab Out Of Specification (OOS), Out Of Tolerance (OOT) investigations, and material non-conformance investigations.
· Conduct hands-on training for all QC chemists and technicians.
· Maintain the laboratory in compliance with the company’s cGMP and Environmental Health and Safety (EH&S) procedures.
Required skills :
· BS/MS in chemistry major with minimum 4 years of pharmaceutical experiences, preferably from QC function in CDMO setting.
· Working knowledge with USP procedures, ICH guidelines, and regulatory guidelines.
· Hands-on experiences in the analysis of small molecule pharmaceutical API and/or ingredients
· Proficiency in operating analytical instrumentations, such as HPLC, LC/MS, GC, GC/MS, TOC, UV-vis, Particle size analyzer and wet chemistry under GMP guideline.
· Must enjoy the dynamic and fast-paced CDMO environment,
· A team player that cherishes the collaborative working relationship while maintaining individual accountability
· Ability of multitasking and prioritizing under stringent timeline
· Excellent communication abilities along with good document practices.
Position location
Job location
USA, Massachusetts, Devens