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Quality Assurance Engineer
Seranbio
Bend, USA
Full-time
Mid Level
Onsite
Discovered 1 weeks ago
Free
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- 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
- 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
- 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
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