Total Quality Senior Specialist jobs in Bend, OR

Serán is looking to fill the need of a laboratory software subject matter expert for a growing Quality Control department. The role of Quality Control Senior Specialist, Applications supports the analytical laboratory software. This position is accountable for the development, implementation, and maintenance of QC applications and end user skills development and training. Responsibilities include application subject matter expert (SME) for client and regulatory inspections. This role will support ensuring day to day high availability of critical laboratory applications. Preference will be given to applicants that have experience with several analytical instrumentation and laboratory-based software systems specifically for the manufacturing of pharmaceutical drug products within a regulatory environment. Collaboration and training are key characteristics of this role, making successful candidates those who can demonstrate the ability to work on cross-functional teams and meet competing deadlines. Those with experience directly with Empower software are strongly encouraged to apply.

• SME for critical lab applications (Empower, Lims, Bruker, Thermo FTIR, Tiamo, etc.)
• Support development of validation documentation for QC applications (URS, RA, FS/DS, TM, Val Protocols, SOP’s, etc.)
• Support execution of validation protocols for QC applications
• Develop and maintain usage SOP and training guidelines for QC applications
• Collaborate with IT, Business, Vendors and consultants to plan and coordinate application updates and version upgrades
• Ensure usage compliance with industry best practices as well as regulatory requirements
• Participate in and ensure adherence to the Serán Change Control process
• Collaborate with QC, QA and IT to support application and system lifecycle management
• Support training users on specific applications
• Provide guidance and support for preparation of internal and external regulatory inspections and observations as related to quality applications
• Performs other duties as assigned

• Experience in supporting regulatory inspection and audits
• Strong and demonstrated understanding of regulatory requirements
• Previous experience supporting validation efforts including authoring validation deliverables such as risk assessments, validation plans, test plans, test scripts and summary reports
• Working knowledge of the drug development process, change management, GxPs, 21 CFR Part 11/Annex 11 and related regulations & guidance
• Understanding of software development methodologies and concepts
• Strong oral and written communication skills in English
• Strong skills in team facilitation, team organization, communication of priorities, and listening
• Excellent organizational skills and attention to detail
• Excellent time management skills with a proven ability to meet deadlines
• Strong analytical and problem-solving skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to function well in a high-paced and at times stressful environment
• Proficient with Microsoft Office Suite or related software

• B.S. in Biological Sciences, Pharmaceutics, Engineering, or similar discipline; or equivalent combination of education and work experience 
• Requires 7 years of experience in the pharma industry, with 5 years of GMP experience and 5 years hands on experience with analytical instrumentation 

• Prolonged periods of sitting or standing at a desk and working on a computer
• Must be able to lift up to 25 pounds at times

Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

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. Serán fully funds employees and their household with dental, vision and one medical plan option. 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.