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Selkirk Pharma is building a state-of-the-art pharmaceutical manufacturing facility in Spokane, WA. This facility will require employees who are able to meet the challenge of using the latest generation of manufacturing software to create the electronic work instructions and records that are needed to document the manufacturing of drug products. The ideal employee will have familiarity with using software programs to develop complex work instructions as well as some understanding of how clean manufacturing works. This person will be the focal point for creating product batch records and will also work with other departments to support the flow of manufacturing processes, inventory movement and other Enterprise Resource Management functions. They will direct the coordination of standard work practices assuring alignment of supporting systems and reports, providing training, audit file monitoring and troubleshooting, as well as ongoing data management.
As a Business Systems Professional, they are responsible for SOP management for their area. They will reassess the business processes at intervals to eliminate non-value-added activities and drive continuous improvement.
Responsibilities can include but not limited to:
- Manage Electronic Batch Record design, revision and configuration changes, Change Control, Process Reviews and alignment with associated documentation.
- Supporting end users on Electronic Batch Record execution/usage.
- Participate in process mapping of client manufacturing processes and translate the client manufacturing process maps into Electronic Batch Records.
- Be the first point of contact for Electronic Batch Record manufacturing issues.
- Escalation of Electronic Batch Record execution issues to department management and supporting teams.
- Obtain and maintain thorough knowledge of Electronic Batch Record system, recipe design, baseline configuration, writing and executing functional verification protocols and reports.
- Conducting trainings to executing personnel on Electronic Batch Record system when upgrades are made to the system or recipes.
- Handling of Enterprise Resource Planning / Electronic Batch Record-related issues and shop floor support.
- Coordinate supporting functional departments for smooth operation of production activities when reviewing and developing batch records.
- Reassess and participate in an agile change environment to enhance the process at intervals to eliminate non-value-added activities and drive continuous improvement including supporting projects and deployments.
- Participate in cross functional teams to support, enhance, and upgrade Selkirk business practices and procedures.
Quality Management and Compliance:
- Ensure all the performed activities comply with Standard Operating Procedures and company best practices. Translate regulatory and business requirements into a robust data design which is compliant, efficient, and effective.
- Initiate change controls related to Electronic Batch Records and the Electronic Batch Record System. Ensure the closure and implementation of changes within a specific time.
- Identify deviations/exceptions and escalate to department managers via appropriate procedures.
- Participate or lead follow ups to Electronic Batch Record-related Incidents and Corrective/Preventive Actions and ensuring long term issue resolution.
- Participate in internal & external (Regulatory & non-Regulatory) audits.
- Assist Manager in controlling, tracking and periodic Electronic Batch Record procedure updates.
- Attend the training of all applicable procedures as per schedule.
- Training the team on relevant procedures and obtain training on respective area of work.
- Develop content and provide Electronic Batch Record training to new hires and refresher training as needed to end users.
- Education: Associate’s or Bachelor’s Degree in Computer Information Systems, Information Technology, Industrial Engineering, Business or Related Field from an accredited college or university. Certification from an accredited Technical or Vocational program will also be considered in lieu of academic degree.
- Experience: 2-5+ years pharmaceutical experience. Knowledge of Good Manufacturing Practices and Food and Drug Administration requirements a plus.
- Computer Skills: Experience in Electronic Batch Record Design and Authoring required. Proficiency in Microsoft office suite products (Word, Excel, Visio, PowerPoint, Outlook) required.
- Language Skills: Communicate effectively and professionally both verbally and in writing.
- Visual Suite, HTML, Java, or object oriented programming.
- Working knowledge focused in Systems Analysis/Data Management.
- Experience with Enterprise Resource Planning and/or Quality Management Software a plus.
MENTAL & OTHER SKILLS/ABILITIES:
For an employee to succeed in this position they must have:
- Contribute to our organizational culture of sincerity, gratitude, enthusiasm, humility, and teamwork.
- Be flexible and adapt to changes, expectations, or unexpected events while maintaining professionalism.
- Prioritize tasks, manage competing demands, and change approach to best fit the situation.
- Collect, analyze, and utilize critical thinking to interpret and report on information and spot trends.
- Consistently complete tasks on time while ensuring accuracy and quality expectations are met.
- Follow instructions, identify errors, formulate alternative solutions, and take corrective action as needed.
- Be willing to constructively apply feedback to improve performance and generate ideas to improve and promote quality in work.
- Maintain respectful and professional relationships with others.
- Interact, communicate and collaborate effectively and professionally with colleagues, clients, auditors, regulatory representatives, and consultants.
- Make prudent and timely decisions and exhibit sound and accurate judgment.
- Perform mathematical calculations and perform complex data analysis.
Occasional travel may be required (<5%)
If you meet our qualifications and you are motivated by working in a highly energetic, collaborative environment, we invite you to apply for this position by utilizing the following link: https://www.applicantpro.com/openings/selkirkpharma/jobs/2056772-574746. As a condition of employment, proof of full COVID-19 vaccination series is required.
Selkirk Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
NOTE: Selkirk does not engage with recruitment services. All resumes / cover letters / applications / etc. sent to Selkirk are considered a direct application without representation. Selkirk does no compensate for recruitment services.