Manager, Quality Assurance – GxP Auditing (GMP-GDP) - Remote
Axsome Therapeutics IncSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
Candidates should possess a Bachelor’s degree or equivalent formal academic/vocational qualification and at least 2+ years of relevant experience. Strong preferred knowledge of HPLC, dissolution, or GC is required, along with previous experience with formal data review in a GMP lab and method validation data review. Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP is also preferred.
Responsibilities
The Data Reviewer performs review of routine and complex analytical analysis experiments on pharmaceutical and biopharmaceutical compounds, ensuring adherence to validated procedures and comparing results to specifications. They evaluate laboratory data for compliance, communicate findings to lab staff, escalate significant deficiencies, and facilitate discussions on documentation practices. Additionally, the Data Reviewer identifies and supports process improvement initiatives, advocates for quality, and performs other duties as assigned.
Skills
GMP
HPLC
Analytical Chemistry
Data Review
Laboratory Procedures
Quality Assurance
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
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.
Key Metrics
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees