Specialist/Sr. Specialist Quality Systems- Temporary
South San Francisco, CA
Quality Assurance /
Temporary /
Hybrid
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history
We are seeking a highly motivated individual to join as Specialist/ Senior Specialist, Quality Systems at our South San Francisco location. The successful candidate will provide assistance for the Document Control program, including day-to-day document processing, document archiving, and supporting continuous improvement of document and user databases.
Work cross functionally to receive, categorize and route GxP documents. Implement and maintain quality assurance systems and processes, supporting Alector’s operations.
Responsibilities Include:
- Help to support the management and maintenance the electronic document management system ensuring Controlled Documents are processed in accordance with Alector SOPs including creation, revision, approval, and obsoletion of Controlled Documents.
- Help to support the management and maintenance of the training system ensuring new users are trained, accounts are set up appropriately, and the system remains in a state of compliance.
- Receive, categorize, and initiate workflows in the electronic data management system
- Track documentation workflow progression within other functional areas and QA, providing routine updates and reminders, and escalating as required
- Provide status reports and quality metrics to support the Quality management review process.
- Ensure current versions of controlled GMP documents are readily available and maintained the Veeva Vault, Including an SOP index and training compliance reporting as required
- Maintain internal formatting standards and ensure all documentation are formatted accordingly. Formatting may include creating templates, fonts and style, pagination and numbering, and any other activities required to achieve document requirements. Contributes to continuous improvement of document templates
Requirements:
- Minimum of 5 -8 years of Quality Assurance experience in the Pharmaceutical/Biotech Industry.
- Experience in the use of validated computer systems for the management of regulated documents and training, including electronic records and electronic signatures.
- Experience with Veeva Vault is required.
- Experience with ComplianceWire, preferred.
- Experience in maintaining cGMP compliance, preferred.
- Excellent organizational skills and the ability to handle multiple priorities and projects.
- Excellent communication skills with the ability to interact with all levels throughout the organization.
- Strong written and verbal communication skills as well as attention to detail
$35 - $55 an hour
Temporary salary ranges will be determined by the candidate’s level, qualifications, skill set, and experience.
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At Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together.
Among the things you'll discover at Alector from your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us!
We believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
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