Manager, Quality Assurance - GxP (GCP Auditing) Remote
Axsome Therapeutics Inc- Full Time
- Junior (1 to 2 years)
Candidates should possess a Bachelor's degree or equivalent formal academic/vocational qualification, along with at least 2+ years of relevant experience providing the knowledge, skills, and abilities to perform the job, or an equivalent combination of education, training, and experience. Expert knowledge of SOPs and Federal Regulations, including GLP and GMP, is required, as well as expert knowledge of chromatography or other applicable analytical techniques and divisional SOPs.
The Senior QC Reviewer will perform complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness, validating large and/or non-routine projects, reviewing sample results for completeness and accurate representation of the data and reports findings, providing expert knowledge in one or more analytical techniques (ELISA, HPLC, CE-SDS, cIEF, SPR, and qPCR) to assist laboratory and quality groups make informed decisions, communicating with laboratory staff to proactively address the quality of laboratory documentation, preparing QC statements noting deficiencies with the analytical data set or notebooks, training new QC Reviewers and laboratory staff, assisting the departmental manager or supervisor in the evaluation of the laboratory QC program, and performing other duties as assigned.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.