Quality Control Associate I/II (Biotech) (FT) Job at Access to Advanced Health Institute
Access to Advanced Health Institute is a Seattle-based nonprofit biotech institute that is undergoing a transformation to lead a global coalition to fight infectious disease and address health disparities and inequities worldwide. We think it’s unfair that where a person lives or how much money they make dictates their access to life-changing medicine. We’re looking for people who want to join us in increasing accessibility to tools that harness the immune system and allow a healthy life, free of illness and disease, regardless of geography or socio-economic status – from compassion and collaboration come change.
We will serve as a center for innovation and collaboration in vaccine and cancer immunotherapy research and development, early-phase GMP manufacturing, and training the next generation of scientists and manufacturing teams to achieve our mission. This is where the high-quality science of an academic research organization and the product-development capabilities of a biotech company meet.
Summary
AAHI is seeking positive candidates with an eye for detail to join our QC team. The QC Associate works in quality control laboratories, using complex instrumentation and laboratory equipment to conduct tests and analyses in a GMP Manufacturing setting. The QC Associate performs analytical tests, gathers and assesses data from those tests, and writes documentation and reports. Exact title to be determined based on qualifications and experience.
Quality Control Associate I range: $46,000 - $56,000 per year.
Quality Control Associate II range: $54,000 - $66,000 per year.
Responsibilities:
- Performs and analyzes quality control testing on incoming samples, in-process materials, and finished product samples related to various manufacturing campaigns.
- Performs testing of routine samples (e.g., raw materials, stability) using established methods and performs testing of non-routine samples (e.g., validation protocol, customer complaints) using established methods. Thoroughly completes all appropriate documentation including lab notebooks and raw data printouts.
- Performs 100% in process visual inspection on aseptically-filled drug products.
- Performs routine equipment cleaning and maintenance following established documents.
- Participates in compliance investigations and technical troubleshooting through analysis and creative problem-solving and/or additional experimentation.
- Supports environmental monitoring as required including growth promotion, plate enumeration, gram stain and colony morphology.
- Prepares protocols and written reports of experimental findings including conducting critical, scientific evaluations; reviews notebooks and reports of peers.
- Prepares solutions and reagents.
- Prepares and receives sample and supply shipments.
- Design and perform analytical activities supporting new method development projects, actively contributing to the development and implementation of project plans, strategies, and team decisions.
- Performs other duties as assigned
- Ensures that all job responsibilities are performed and documented accurately; timely; and in compliance with SOPs, cGMPs and FDA requirements
Requirements
- BS/BA degree in a biological science and 1+ years of experience in a regulated laboratory environment
- 0 to 4 years' experience working in a similar role
- Excellent oral and written communication skills.
- Proficiency in MS Office and file management.
- Must be self-motivated, organized and be able to work on teams.
- Possess a work ethic that includes integrity, accountability, accuracy, neatness, and punctuality.
- Trainability and willingness to learn analytical methodology pertaining to the handling, logging, inventory of routine and non-routine samples.
- Trainability and willingness to learn analytical techniques, documentation, SOPs, as they pertain to cGMP procedures.
- Ability to take initiative and prioritize tasks; good time-management, problem-prevention, and problem-solving skills. Flexibility in performing multiple tasks.
- Good written and oral communication skills; ability to communicate effectively.
- Ability to maintain comprehensible and accurate lab records.
- Ability to work independently and as part of a team; ability to motivate self.
- Ability to work accurately with close attention to detail.
- Ability to maintain confidentiality of sensitive information.
- Ability to work with co-workers and outside agencies professionally and tactfully.
Benefits
We offer a comprehensive compensation plan which includes:
- Medical, Dental, Vision
- Up to 6 weeks' Vacation & Sick pay
- Group Life, AD&D, Short & Long-term disability, Hospital Indemnity, Accident
- Flexible Spending Accounts (HSA and Dependent Care)
- Matching 401(k) Retirement Plan
- Commuter benefits
- Employee Assistance Plan (EAP)
- Flexible work schedule
- Mindfullness/Fitness App Subscription
- Voluntary & Lifestyle Benefits
Vaccination Requirement:
Due to the threat of more infectious and deadly COVID-19 variant strains emerging, we recently announced a new mandatory vaccination policy requiring our employees to be fully vaccinated against COVID-19 as a condition of employment. We will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. With this policy, AAHI joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of employees and the community.
We do not discriminate. We are an equal opportunity employer and are committed to inclusion and encourage everyone to bring their full selves to work. We are an E-Verify Employer.
About Access to Advanced Health Institute:
AAHI is a nonprofit biotech research institute, bringing together the best experts, technologies, and platforms to create accessible, high-quality products and solutions for harnessing the immune system to alleviate disease. We are building a world where every person has access to tools that harness their immune system and allow them to live a healthy life, free of illness and disease.
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