Operational Supply Documentation Specialist at Acadia Pharmaceuticals

Buenos Aires, Buenos Aires, Argentina

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Degree in Pharmacy, Chemistry, or Engineering
Minimum of 5 years of experience in comparable roles
Intermediate to Advanced English proficiency
Proficiency in the Microsoft Office Suite
Strong verbal and written communication abilities
Proven aptitude for teamwork and collaboration
Ability to adapt to agile environments and a strong results orientation

Responsibilities

Draft, review, and maintain Standard Operating Procedures (SOPs) for the BIMSA Supply sector
Identify documental improvement opportunities within the sector
Draft, review, and track Change Controls (CDC) related to Supply Operations (e.g., layout changes, new equipment, materials, systems, or procedures)
Evaluate the documentary impacts resulting from changes and ensure the update or creation of affected SOPs
Provide support to the sector in the investigation of operational, documentary, or procedural deviations detected in the area
Manage the CAPA plans applicable to the sector
Conduct training sessions for sector personnel
Participate in audits
Ensure the management, updating, and traceability of GMP documentation associated with logistics operations, warehouses, and the weighing/dispensing center, guaranteeing compliance with regulatory standards and corporate policies
Act as a key liaison between Supply Operations, Quality Assurance, and Engineering, actively participating in Change Controls (CDC), deviation investigations, and GMP improvement or adaptation projects within the Supply area

Skills

GMP

SOP

Change Controls

Deviation Investigations

CAPA

Microsoft Office

English Proficiency

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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