Senior Credit Quality Assurance Analyst
M&T BankSalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Analista para Aseguramiento de la Calidad at Acadia Pharmaceuticals
Buenos Aires, Buenos Aires, Argentina
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries
Requirements
- Minimum of 3 years of experience with solid GMP knowledge gained in pharmaceutical companies
- Experience in managing CAPAs, OOSs, and Deviations
- Strong writing skills and attention to detail
- Desirable: Proficiency in Trackwise
Responsibilities
- Write and review SOPs and associated change controls
- Review investigations associated with deviations, ensuring compliance with internal, global standards, and GMP regulations
- Review investigations associated with OOS/OOT occurrences, ensuring compliance with internal, global standards, and GMP regulations
- Track and follow up on deviations and CAPAs, ensuring closure within established timelines
- Provide support to sectors on issues related to deviations, OOS/OOT, and CAPAs
- Contribute to quality audits across various sectors
- Participate in risk analysis and the treatment of claims
Skills
GMP
SOPs
CAPAs
Deviations
OOS
OOT
Trackwise
Quality Audits
Risk Analysis
Acadia Pharmaceuticals
Develops therapies for neurological disorders
About Acadia Pharmaceuticals
Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.
Dallas, TexasHeadquarters
1993Year Founded
$813.4MTotal Funding
ACQUISITIONCompany Stage
Biotechnology, HealthcareIndustries
501-1,000Employees
Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Retirement Plan
401(k) Company Match
Employee Stock Purchase Plan
Paid Vacation
Paid Holidays
Paid Sick Leave
Paid Parental Leave
Tuition Reimbursement
Risks
Increased competition in CNS drug market may impact Acadia's market share.
Potential clinical trial delays could affect drug approval timelines.
Dependence on partnerships poses risks if collaborations face challenges or dissolve.
Differentiation
Acadia focuses on CNS disorders with unmet medical needs, like Parkinson's and Rett syndrome.
The company has a strong R&D foundation, developing innovative small molecule drugs.
Acadia's strategic partnerships enhance its research capabilities and market reach.
Upsides
Acadia's collaboration with Saniona expands its portfolio with SAN711 for neurological disorders.
Health Canada's approval of Daybue boosts Acadia's presence in the Canadian market.
The rise of personalized medicine aligns with Acadia's targeted therapy approach.
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