Quality Assurance Associate II/III

Serán BioScience is searching for an experienced Quality Assurance Associate to aid in regulatory compliance for the manufacturing of oral solid dosage drug products. As a Quality Assurance Associate, you will be responsible for performing the day-to-day tasks of the QA Department supporting a GMP facility manufacturing and testing pharmaceutical products. Tasks include auditing and audit support, supplier quality management, and continuous improvement. Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA. Preference will be given to candidates with Quality Assurance experience in the pharmaceutical industry, while those with Quality oversight experience are encouraged to apply.Duties And ResponsibilitiesParticipates in internal and third-party auditsSupports client audits and regulatory inspectionsSupports company’s supplier quality programAssists in the oversight and implementation of continuous improvement of the company’s Quality systems Supports the risk management program and conducts risk assessmentsDocument authorship, review, and approval of SOPs, reports, and quality recordsOther related duties as assigned Required Skills And AbilitiesKnowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211)Excellent verbal and written communication skillsExcellent time management skills with a proven ability to meet deadlinesExcellent organizational skills and attention to detailDemonstrated ability to collaborate and work in cross-functional teamsScientific curiosity and willingness to learnStrong analytical and problem-solving skillsAbility to prioritize tasks and to delegate them when appropriateEducation And ExperienceMinimum of a Bachelor's Degree, preferably in a scientific discipline 3+ years previous manufacturing, quality control, or quality assurance experience Working knowledge of Veeva preferredPhysical RequirementsProlonged periods of sitting or standing at a desk and working on a computerMust be able to lift up to 15 pounds at timesAbility to wear required personal protective equipment (PPE), including safety glasses, hearing protection, hard hat, and safety shoesAdheres to consistent and predictable in-person attendanceVisit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.Benefits Summary:Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.