Manager, Quality Assurance - GxP (GCP Auditing) Remote
Axsome Therapeutics IncSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Expert & Leadership (9+ years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalIndustries
Requirements
Candidates should possess a minimum of 8 years’ experience in the Pharmaceutical Industry and a minimum of 5 years’ experience in Pharmaceutical Quality Assurance, with a Bachelor’s Degree in a scientific field preferred. Strong attention to detail and proficient computer skills are required, along with ASQ Certification being preferred.
Responsibilities
The Manager II, Quality Assurance will be responsible for reviewing and processing manufacturing Deviations and Laboratory OOS, reviewing manufacturing-related Change Controls within Tarsus’ QMS system, authoring Annual Product Reviews, analyzing and trending analytical data, approving Certificates of Analysis, reviewing manufacturing batch records and product disposition, reviewing Vendor Change Controls and vendor documents, reviewing product and material Specifications, conducting Internal Audits, reviewing Test Record Review Forms and Certificates of Analysis, and reviewing and approving executed manufacturing batch records and packaging batch records. The role will also involve collaborating in meetings with Tarsus’ manufacturing partners and testing, and participating in internal Operations.
Skills
Deviations
OOS
Change Controls
QMS
Annual Product Reviews
Analytical Data
Certificates of Analysis
Batch Records
Vendor Change Controls
Specifications
Internal Audits
Test Record Review Forms
Product Disposition
Tarsus Pharamceuticals
Develops treatments for eye care diseases
About Tarsus Pharamceuticals
Tarsus Pharmaceuticals develops treatments for diseases that lack effective solutions, focusing mainly on eye care and infectious diseases. Their key product, XDEMVY, is an FDA-approved eye drop solution used to treat Demodex Blepharitis, a condition affecting the eyelids. The company is also working on other potential treatments for conditions such as Lyme Disease Prevention, Meibomian Gland Disease, and Rosacea. Tarsus differentiates itself from competitors by concentrating on specific medical needs and maintaining a strong pipeline of future products. Their goal is to provide effective treatments for patients suffering from these conditions while ensuring compliance with regulations and ethical standards.
Key Metrics
Irvine, CaliforniaHeadquarters
2017Year Founded
$58.4MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
201-500Employees