Open Position: Quality Assurance Specialist
STATUS: Full-time, Regular
REPORTS TO: QSM Lead
TARGET START: Immediately
Lumen is seeking a highly motivated, detail-oriented Quality Assurance Specialist.
The QA Specialist is responsible for managing tasks associated with maintaining a quality management system, including conducting cGMP facility walkthroughs, auditing documentation compliance, and maintaining production records.
Essential Duties and Responsibilities
This position requires working under the cGMP quality system processes.
The key duties and responsibilities for this position are as follows:
Conduct facility and operations walkthroughs, observations, and process audits to ensure compliance with the Company’s food safety and quality system processes
Maintain accurate records of activities
Review process documentation and contribute to continuous improvements in safety, quality, and efficiency
Assist with preparation and execution of internal and 3rd party audits and other reviews
Desired and Required Qualifications
Experience and education:
4 or more years of relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing/QC or QA, and a Bachelor’s degree in science, ideally in food science, microbiology, or related discipline
8 or more years of relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing/QC or QA, and Associate’s degree in science, ideally in food science, microbiology, or related discipline
Requires knowledge of and experience with relevant cGMP and ISO 9001 requirements for document control and quality records
Experience working with clinical and commercial products and supporting internal and external audits, and regulatory inspections desired
The successful application will have the following attributes:
Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask
Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment
Capable of supporting multiple projects simultaneously in a deadline-driven environment
Adaptability, flexibility, independence and resourcefulness to thrive in a fast-paced, small-company environment
High level of proficiency in Microsoft Word, Excel, and Sharepoint.
High integrity and ethics
Commitment to quality and timely delivery of results; committed to continuous improvement
Ability to work effectively at a fast pace with cross functional departments
Ability to anticipate and mitigate challenges
Sit for extended periods of time (2 or more hours)
Occasionally lift or carry up to 20 kg
Please submit a resume and cover letter to firstname.lastname@example.org with the position title in the subject title.
This position is available immediately. Applications will be reviewed upon receipt. Only successful applicants will be contacted.
Lumen Bioscience was founded in early 2017 to make and commercialize ultra-low-cost biologics, such as antibodies, in our proprietary spirulina expression platform. We design and manufacture therapeutics against disease targets that have been inaccessible to the pharmaceutical industry because of the astonishingly high cost of using traditional methods to make and deliver biologic drugs. Now, for the first time, Lumen can make antibodies and other biologics at a cost that allows for daily, high-dose, oral delivery.
Our current programs focus on diseases that can be prevented or treated by an orally delivered therapeutic; the target markets are enormous, the treatment modes of action are well-researched, and the unmet medical need is obvious. We have been fortunate to have earned financial support for these programs from groups like the Bill & Melinda Gates Foundation and the NIH. In the longer term, we believe that our unique technology–––the ability to safely deliver frequent, large doses of a wide range of biologic compounds–––will become commonplace in biopharma as the science continues to advance and uncover new opportunities in the fields of microbiome signaling, metabolism, inflammation, and oral delivery of systemic biologics.
The Lumen team works out of a beautiful lab and office facility in Fremont, a picturesque neighborhood on the north shore of Lake Union in the heart of Seattle. At Lumen, you'll be challenged, you'll be inspired, and you'll be proud to be part of an innovative organization making a real impact on improving the quality of life globally.
Lumen is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
NOTE TO EMPLOYMENT AGENCIES: Lumen values its relationships with recruitment partners and will only accept resumes from those partners that have been contracted by a member of the human resources team. Lumen is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Lumen who is not a member of the human resources team.