Contract - QA Document Control Specialist at Cytokinetics

South San Francisco, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

Minimum of 5 yrs of experience performing Document Control & Training
Knowledge of Veeva Vault Quality Docs and Training required
Must be highly organized with a strong attention to detail and comfortable working in a fast-paced environment
Must have advanced skills in MS Office Suite, particularly in Word document processing and formatting
Experience writing, reviewing and editing SOPs, as well as other document types
Ability to work in a collaborative team environment is essential, with a customer-focused approach
Must have strong interpersonal and communication skills
Knowledge of GXP regulations and guidelines, as it pertains to Quality Systems preferred

Responsibilities

Manage and process controlled documents in the electronic document management system throughout their lifecycle (e.g. SOPs, Policies, Work Instructions, Forms)
Perform formatting and editing of controlled documents to ensure consistency and compliance prior to routing for document approvals
Provide guidance and training to document owners/authors, collaborators, and approvers throughout the document management lifecycle
Track training, prompting employees to complete training on time

Skills

Veeva Vault

Quality Docs

Quality Training

MS Office

MS Word

Document Control

SOP Writing

SOP Editing

Document Formatting

QMS

Cytokinetics

Develops drugs for muscle function disorders

About Cytokinetics

Cytokinetics focuses on developing medicines that improve muscle function for patients with cardiovascular and neuromuscular diseases. Their products are small molecule drugs designed to either enhance or inhibit muscle function, tailored to specific therapeutic needs. The company has a pipeline of drugs, including omecamtiv mecarbil and reldesemtiv, which are in various stages of clinical trials. Unlike many competitors, Cytokinetics emphasizes rigorous scientific research and has conducted over 50 clinical trials to ensure the effectiveness of its treatments. The goal is to bring new therapies to market that address the unmet needs of patients suffering from conditions like heart failure, ALS, and HCM.

South San Francisco, CaliforniaHeadquarters

1998Year Founded

$58.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Risks

Increased competition could impact market share and profitability.

Potential delays in clinical trials could hinder drug commercialization.

Dependence on strategic partnerships may expose Cytokinetics to risks if challenges arise.

Differentiation

Cytokinetics focuses on muscle activators and inhibitors for cardiovascular and neuromuscular diseases.

The company has a robust pipeline including omecamtiv mecarbil and aficamten.

Cytokinetics engages in strategic partnerships, like with Sanofi, to expand market reach.

Upsides

Recent investments indicate strong interest in muscle activators and inhibitors.

Strategic partnerships, like with Sanofi, expand market reach and potential revenue.

Significant funding from Royalty Pharma supports commercial launch and R&D advancements.

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