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Serán BioScience

Posted 2 months ago

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Quality Assurance Engineer

Bend, OregonOn-siteFull-time

AI Summary

QA Engineer responsible for qualification/validation activities across facilities, utilities, equipment, processes, cleaning, and computerized systems within a commercial manufacturing facility, ensuring compliance with GMP regulations.

About this role

Serán 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 Responsibilities

  • Generates and/or supports the generation of risk assessments, user requirements specifications (URS), C&Q plans, change controls, SOPs, CAPAs, and other relevant documents
  • Supports 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 state
  • Makes compliance decisions to support commercial operations
  • Mentors colleagues on the reasons or justifications of the requirements and practices
  • Drives process improvement initiatives
  • Provides support during clients and regulatory audits
  • Performs other related duties as assigned
  • Responsibilities may increase in scope to align with company initiatives

    • Required Skills and Abilities

  • Understanding 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 effort
  • Technical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effort
  • Hands-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 team
  • Strong time-management skills and the ability to organize and coordinate multiple projects at a time
  • Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
  • Ability to prioritize tasks and to keep leadership apprised of performance to timelines
  • Accepts feedback from a variety of sources and constructively manages conflict
  • Experience in Oral Solid Dose operations and spray drying is preferable
  • Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems

    • Education and Experience

  • Bachelor’s degree in a science, engineering, or related field
  • Minimum of 4 years required within pharmaceutical industry, with preference given to those with 5-10 years of experience
  • Minimum of 4 years of experience performing qualifications and/or validations is required

    • Physical Requirements

  • Prolonged periods sitting at a desk and working on a computer
  • Prolonged periods of mobility between offices and campus buildings
  • Adheres to consistent and predictable in-person attendance

    • Skills

    21 CFR 21021 CFR 21121 CFR Part 11AuditsCAPAsChange ControlsCompliance DecisionsC&Q PlansCross-functional TeamworkDiscrepanciesEnterprise SystemsEudraLex Volume 4 Annex 15GAMP 5Microsoft OfficeOral Solid Dose OperationsPeriodic ReviewsProceduresRequalificationRisk AssessmentsSOPsSpray DryingURSValidation Lifecycle

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