Quality Assurance Engineer

Quality Assurance EngineerSerán BioScience is expanding and looking for a Quality Assurance Engineer with industry experience to join at this exciting time. The QA Engineer will be part of a cross functional team that will be responsible for the review and/or approval of qualification/validation of all the lifecycle activities associated with facilities, utilities, equipment, process, cleaning, and computerized systems. The focus of this position will be to support the Commercial Manufacturing Facility that is currently underway.The development and execution of these deliverables requires direct communication with internal and external cross functional teams. Successful candidates will understand that effective communication is essential for alignment on strategies and approaches, and correcting deficiencies while maintaining good working relationships. Qualified candidates will have a thorough understanding of current regulations and guidelines such as but not limited to 21 CFR Parts 11, 210, and 211, EudraLex Volume 4, Annex 15, and GAMP 5 is required.Duties and ResponsibilitiesGenerates and/or supports the generation of risk assessments, user requirements specifications (URS), C&Q plans, change controls, SOPs, CAPAs, and other relevant documentsSupports validation lifecycle activities such as, but not limited to, change management, periodic reviews, and re-qualification to ensure that qualified systems remain in their validated stateMakes compliance decisions to support commercial operationsMentors colleagues on the reasons or justifications of the requirements and practicesDrives process improvement initiativesProvides support during clients and regulatory auditsPerforms other related duties as assignedResponsibilities may increase in scope to align with company initiativesRequired Skills and AbilitiesUnderstanding of current regulations and guidelines (e.g., 21 CFR Parts 11, 210, and 211, EudraLex Volume 4 - Annex 15, GAMP 5, etc.) and how to apply them to support the validation effortTechnical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effortHands-on experience with the qualification of facilities, utilities, equipment and/or computerized systems, cleaning or process validation (Experience in at least two of these areas is required)Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional teamStrong time-management skills and the ability to organize and coordinate multiple projects at a timeCommunicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the CompanyAbility to prioritize tasks and to keep leadership apprised of performance to timelinesAccepts feedback from a variety of sources and constructively manages conflictExperience in Oral Solid Dose operations and spray drying is preferableProficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systemsEducation and ExperienceBachelor's degree in a science, engineering, or related fieldMinimum of 4 years required within pharmaceutical industry, with preference given to those with 5-10 years of experienceMinimum of 4 years of experience performing qualifications and/or validations is requiredPhysical RequirementsProlonged periods sitting at a desk and working on a computerProlonged periods of mobility between offices and campus buildingsAdheres to consistent and predictable in-person attendanceLevel and compensation will be based on experience.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.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 97701