Senior Specialist, Quality Lot Disposition

Quality Assurance    ·       South San Francisco, CA       ·       Full time

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration. Our team is solely 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, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

We are seeking a highly motivated individual to join as Specialist/ Senior Specialist, Quality Assurance Lot Disposition at our South San Francisco location. The successful candidate will work cross functionally to develop and implement quality assurance systems and processes, supporting CMC operations, provide timely review and approval of manufacturing batch records to support lot disposition and complete associated procedures to meet all US, EU and potentially global, cGXP requirements. The position will report directly to the Senior Director, Quality.

Responsibilities Include:

• Responsible for the batch record review and disposition activities for bulk drug substance, sterile drug product, clinical packaging and labeling.
• Assist in establishing Quality processes and procedures for disposition of Investigational Products.
• Collaborate with contract service providers and internal teams to address GMP deviations and investigations prior to lot disposition.
• Establish and maintain training on documentation requirements for lot disposition.
• Support inspection readiness and compliance with applicable regulatory standards. Support internal and external audits.
• Establish and maintain lot genealogy and supply chain tables for each of the development programs at Alector.
• Provide status reports and quality metrics to support management review process.
• Assist with product recall/stock recovery investigations and reports, as necessary.

Requirements:

• Bachelors degree in related field with minimum of 6 years’ experience in quality or operations in a pharmaceutical setting.
• Ability to partner with teams collaboratively and constructively.
• Proven, working knowledge of compliance, cGMP requirements and industry practices
• Excellent interpersonal, verbal and written communication skills are essential in our collaborative work environment
• Must demonstrate high organizational and prioritization proficiencies
• Ability to deliver in a fast-paced, small company environment and ability to seamlessly adjust workload based upon changing priorities

#LI-BL1

Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a treatment, where you’ll drive growth, this is your role. There is no limit to how far you can go with us.

Among the things you’ll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly-lit offices in the heart of the biotech area, flexible remote work options, and competitive compensation and benefits. But these matters only if you’re excited to build and own something great, and tackle these challenges with us. Come join us!

At Alector, 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.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief. 

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Please click here to apply.