Quality Assurance Associate II/III (Swing Shift)

Serán BioScience is searching for an experienced Quality Assurance Associate to aid in regulatory compliance for the manufacturing of oral solid dosage drug products. The primary responsibilities of this role will be to support the daily activities of Serán’s Quality Assurance department by ensuring GMP regulations and internal SOPs are followed throughout the clinical manufacturing process. Essential task include reviewing and approving production records, analytical data, and internal QA documentation. Additional responsibilities include conducting risk analyses and investigations and participating in audits and inspections. Quality experience in a GMP Pharmaceutical Manufacturing setting is a requirement for this position with the ability for the title and compensation to commensurate with experience.This role will support the alternative manufacturing schedule from Monday - Thursday, beginning at 2:00 pm and ending at 1:00 am. Experience specific to Serán's manufacturing capabilities and confidence to make independent decisions in alignment with Company policies and risk mitigation philosophies will be critical to this role.Duties And ResponsibilitiesDocuments authorships, reviews, and approves of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualificationsApplies working knowledge of best practices in GMP and understands how Quality integrates with other business areasInitiates and oversees investigationsManages corrective and preventive actions (CAPA)Supports internal audits, client audits and regulatory inspections, with the potential to host Manages controlled document issuance and archivalPerforms quality reviews with minimal oversight Communicates quality-related information to internal teams with minimal guidanceResponsibilities may increase in scope to align with company initiativesPerforms all other related duties as assignedRequired Skills And AbilitiesKnowledge of GMP and FDA regulations for clinical trial materials; commercial knowledge is desirable but not requiredConfident understanding of change control procedures, CAPA program, investigation and root cause analysis, and good documentation practicesExcellent organizational skills and attention to detailExcellent time management skills with a proven ability to meet deadlinesStrong analytical and problem-solving skillsCommunicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the companyDemonstrates the ability to collaborate and work in cross-functional teamsAccepts feedback from a variety of sources and constructively manages conflictAbility to prioritize tasks and to delegate them when appropriateExcellent verbal and written communication skillsAbility to function well in a high-paced and at times stressful environmentProficient with Microsoft Office Suite or related softwareAbility to solve complex problems, take a new perspective on existing solutions, and exercise sound judgment based on the analysis of multiple sources of information to make independent decisionsEducation And ExperienceBachelor’s degree, preferably in a scientific discipline3 years of GMP experience within a QC or QA role to meet the minimum qualifications for an Associate II6 years of GMP experience within a QC or QA role to meet the minimum qualifications for an Associate IIIPharmaceutical Manufacturing experience required, Oral Solid Dosage 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.