Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and Preventive Actions (CAPA), Risk management and impact assessments ...
Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and Preventive Actions (CAPA), Risk management and impact assessments ...
Manages change control processes and deployment governance activities. * Conducts risk assessments and develops mitigation strategies to ensure successful project outcomes. * Coordinates User ...
Quick apply
Manages change control processes and deployment governance activities. * Conducts risk assessments and develops mitigation strategies to ensure successful project outcomes. * Coordinates User ...
Manages change control processes and deployment governance activities. * Conducts risk assessments and develops mitigation strategies to ensure successful project outcomes. * Coordinates User ...
Manages change control processes and deployment governance activities. * Conducts risk assessments and develops mitigation strategies to ensure successful project outcomes. * Coordinates User ...
Manages change control processes and deployment governance activities. * Conducts risk assessments and develops mitigation strategies to ensure successful project outcomes. * Coordinates User ...
Manages change control processes and deployment governance activities. * Conducts risk assessments and develops mitigation strategies to ensure successful project outcomes. * Coordinates User ...
... change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices * Excellent organizational skills and attention to detail * Excellent time management ...
... change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices * Excellent organizational skills and attention to detail * Excellent time management ...
... change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices * Excellent organizational skills and attention to detail * Excellent time management ...
Quick apply
... change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices * Excellent organizational skills and attention to detail * Excellent time management ...
... change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices * Excellent organizational skills and attention to detail * Excellent time management ...
... change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices * Excellent organizational skills and attention to detail * Excellent time management ...
Nurse Manager - Progressive Care Unit
Bend, OR · On-site
$147K - $228K/yr
Manages staffing and scheduling (control of master schedule; ETO & LOA approval; light duty ... This unit will also follow an acuity adaptable model to allow the improved change in acuity of the ...
Nurse Manager - Progressive Care Unit
Bend, OR · On-site
$147K - $228K/yr
Manages staffing and scheduling (control of master schedule; ETO & LOA approval; light duty ... This unit will also follow an acuity adaptable model to allow the improved change in acuity of the ...
... change control processes * Provide Quality Assurance/Quality Control (QAQC) oversight of ... Manage vendor relationships for electrical maintenance and retrofit work * Provide feedback on ...
... change control processes * Provide Quality Assurance/Quality Control (QAQC) oversight of ... Manage vendor relationships for electrical maintenance and retrofit work * Provide feedback on ...
Ownership of manufacturing process equipment and involvement in equipment lifecycle management ... and change control activities. * Support equipment qualification and process improvement ...
Ownership of manufacturing process equipment and involvement in equipment lifecycle management ... and change control activities. * Support equipment qualification and process improvement ...
Ownership of manufacturing process equipment and involvement in equipment lifecycle management ... and change control activities. * Support equipment qualification and process improvement ...
Ownership of manufacturing process equipment and involvement in equipment lifecycle management ... and change control activities. * Support equipment qualification and process improvement ...
3rd manager
La Pine, OR · On-site
$20 - $22/hr
... change. Occasionally assisting customers to their vehicles with groceries and stocking and facing ... Effectively direct and control work in area of responsibility. * The ability to support and ...
3rd manager
La Pine, OR · On-site
$20 - $22/hr
... change. Occasionally assisting customers to their vehicles with groceries and stocking and facing ... Effectively direct and control work in area of responsibility. * The ability to support and ...
3rd manager
La Pine, OR · On-site
$20 - $22/hr
... change. Occasionally assisting customers to their vehicles with groceries and stocking and facing ... Effectively direct and control work in area of responsibility. * The ability to support and ...
3rd manager
La Pine, OR · On-site
$20 - $22/hr
... change. Occasionally assisting customers to their vehicles with groceries and stocking and facing ... Effectively direct and control work in area of responsibility. * The ability to support and ...
QC Testing Technician IV (Lead) - A Shift - Mon-Thurs, 6am-4:30pm
Redmond, OR · On-site
$19.75 - $25.50/hr
Must be able to communicate effectively with management and co-workers to achieve department and ... Duties, responsibilities and activities may change at a time with or without notice. This is not an ...
QC Testing Technician IV (Lead) - A Shift - Mon-Thurs, 6am-4:30pm
Redmond, OR · On-site
$19.75 - $25.50/hr
Must be able to communicate effectively with management and co-workers to achieve department and ... Duties, responsibilities and activities may change at a time with or without notice. This is not an ...
QC Testing Technician IV (Lead) - A Shift - Mon-Thurs, 6am-4:30pm
Redmond, OR · On-site
$19.75 - $25.50/hr
Must be able to communicate effectively with management and co-workers to achieve department and ... Duties, responsibilities and activities may change at a time with or without notice. This is not an ...
QC Testing Technician IV (Lead) - A Shift - Mon-Thurs, 6am-4:30pm
Redmond, OR · On-site
$19.75 - $25.50/hr
Must be able to communicate effectively with management and co-workers to achieve department and ... Duties, responsibilities and activities may change at a time with or without notice. This is not an ...
Must be able to communicate effectively with management and co-workers to achieve department and ... Duties, responsibilities and activities may change at a time with or without notice. This is not an ...
Must be able to communicate effectively with management and co-workers to achieve department and ... Duties, responsibilities and activities may change at a time with or without notice. This is not an ...
Must be able to communicate effectively with management and co-workers to achieve department and ... Duties, responsibilities and activities may change at a time with or without notice. This is not an ...
Must be able to communicate effectively with management and co-workers to achieve department and ... Duties, responsibilities and activities may change at a time with or without notice. This is not an ...
QC Testing Technician IV (Lead) - A Shift - Mon-Thurs, 6am-4:30pm
Redmond, OR · On-site
$19.75 - $25.50/hr
Must be able to communicate effectively with management and co-workers to achieve department and ... Duties, responsibilities and activities may change at a time with or without notice. This is not an ...
QC Testing Technician IV (Lead) - A Shift - Mon-Thurs, 6am-4:30pm
Redmond, OR · On-site
$19.75 - $25.50/hr
Must be able to communicate effectively with management and co-workers to achieve department and ... Duties, responsibilities and activities may change at a time with or without notice. This is not an ...
Provide leadership to positively influence change. * Promote Turner's involvement in the community ... Manage the Quality Assurance/Quality Control (QA/QC) program. * Provide leadership in risk ...
Provide leadership to positively influence change. * Promote Turner's involvement in the community ... Manage the Quality Assurance/Quality Control (QA/QC) program. * Provide leadership in risk ...
Project Manager (Central Oregon)
Bend, OR · On-site
Provide leadership to positively influence change. * Promote Turner's involvement in the community ... Manage the Quality Assurance/Quality Control (QA/QC) program. * Provide leadership in risk ...
Project Manager (Central Oregon)
Bend, OR · On-site
Provide leadership to positively influence change. * Promote Turner's involvement in the community ... Manage the Quality Assurance/Quality Control (QA/QC) program. * Provide leadership in risk ...
Change Control Manager information
See Bend, OR salary details
$47.5K is the 25th percentile. Wages below this are outliers.
$42.9K - $51.4K
46% of jobs
$51.4K - $60K
0% of jobs
$60K - $68.5K
0% of jobs
$68.5K - $77.1K
0% of jobs
$77.1K - $85.6K
0% of jobs
$85.6K - $94.2K
0% of jobs
$94.2K - $102.7K
0% of jobs
The median wage is $104.5K / yr.
$102.7K - $111.3K
18% of jobs
$111.3K - $119.8K
5% of jobs
$119.8K - $128.4K
5% of jobs
$128.6K is the 75th percentile. Wages above this are outliers.
$128.4K - $136.9K
26% of jobs
$42.9K
$90.3K
$136.9K
How much do change control manager jobs pay per year?
What is a change control manager?
What are the typical challenges faced by a change control manager when coordinating cross-functional teams during change implementation?
What are the key skills and qualifications needed to thrive as a change control manager, and why are they important?
What is the difference between Change Control Manager vs Quality Assurance Specialist?
| Aspect | Change Control Manager | Quality Assurance Specialist |
|---|---|---|
| Certifications | ISO 9001, PMP, or equivalent | ISO 9001, Six Sigma, or equivalent |
| Work Environment | Regulated industries like manufacturing, pharma, biotech | Manufacturing, software, healthcare sectors |
| Primary Focus | Managing change processes, documentation, approvals | Ensuring product quality, testing, compliance |
The Change Control Manager and Quality Assurance Specialist roles often overlap in regulated industries, but their focus differs. The Change Control Manager primarily oversees change processes and documentation, ensuring compliance with procedures. The Quality Assurance Specialist concentrates on maintaining product quality through testing and compliance checks. Both roles require similar certifications and work environments, but their core responsibilities distinguish them within the industry.
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Full-time
PTO
Re-posted 20 days ago
Job description
- Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs
- Supports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic review
- Leads initiatives to modernize validation practices including CSA adoption, digital validation approaches, and automation lifecycle management
- Defines key performance indicators (KPIs) and metrics to measure effectiveness of QualityEngineering and CSA programs
- Provides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activitie
- Provides Quality leadership and oversight of validation programs including:
- Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systems
- Approval and oversight of validation lifecycle documentation including:
- Validation Master Plans (VMP), User Requirement Specifications (URS), Functional and Design Specifications, Risk assessments, IQ/OQ/PQ protocols and reports, & Validation summary reports
- Ensures validation activities comply with internal procedures and regulatory requirements and remain aligned with the site Validation Master Plan
- Provides quality oversight for commissioning, qualification, and validation activities in highly automated manufacturing environments
- Ensures validated systems maintain a continuous state of control throughout their operational lifecycle
- Supports the design and implementation of the organization's Computer System Assurance (CSA) and Computerized System Validation (CSV) programs
- Ensures computerized systems comply with data integrity principles (ALCOA++) and regulatory expectations
- Oversees validation lifecycle management for computerized systems including:
- Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality management systems, Electronic Batch Record Systems, & Enterprise resource planning systems
- Implements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologies
- Leads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systems
- Supports system lifecycle activities including system upgrades, migrations, and decommissioning
- Provides QA oversight and approval for quality system elements impacting validated systems including:
- Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and Preventive Actions (CAPA), Risk management and impact assessments, & Periodic reviews of validated systems
- Ensures that validation and CSA programs remain aligned with corporate policies, regulatory guidance, and evolving industry standards
- Provides QA support for technology transfer, new product introductions, and site capital projects
- Serves as the Quality Engineering representative for site project teams implementing new equipment, systems, or manufacturing technologies
- Supports troubleshooting of complex process or system issues impacting validated systems
- Serve as subject matter expert for validation, computerized systems assurance, and data integrity during regulatory inspections and Client audits
- Leads preparation and inspection readiness programs related to validation and data integrity
- Leads and develops a high-performing Quality Engineering and CSA organization
- Provides mentoring, coaching, and professional development for technical staff
- Establish clear departmental goals aligned with organizational quality and operational objectives
- Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
- Fosters a culture of quality ownership, compliance, and continuous improvement
- Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
- Experience organizing and managing work responsibilities while working independently with minimal oversight
- Deep expertise in Computer System Validation / Computer System Assurance
- Validation lifecycle management, Data integrity regulations and industry guidance, Risk-based validation methodologies
- Time and project management skills with the ability to multi-task and meet deadlines
- Excellent verbal and written communication skills
- Excellent interpersonal and customer service skills
- Excellent organizational skills and attention to detail
- Strong analytical and problem-solving skills
- Strong supervisory and leadership skills
- Ability to prioritize tasks and to delegate them when appropriate
- Willingness to accept feedback from a variety of sources
- Ability to constructively manage conflict
- Ability to collaborate and work in cross-functional teams
- Ability to function well in a high-paced and at times stressful environment
- Ability to maintain productive relationships with coworkers, clients, and other contacts outside the company
- Proficient with Microsoft Office Suite or related software
- Bachelor's degree, preferably in a scientific discipline. Preference will be given to those with an advanced degree
- Minimum of 10+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
- Minimum of 5+ years previous experience with qualification/validation/CSA activities in a QA or Technical capacity
- Demonstrated experience with regulatory inspections by the FDA and EU authorities
- Prolonged periods of sitting or standing at a desk and working on a computer
- Must be able to lift up to 15 pounds at times
- Adheres to consistent and predictable in-person attendance
About Seran BioScience
Sourced by ZipRecruiter
Industry
Manufacturing
Company size
1 - 10 Employees
Headquarters location
Bend, OR, US
Year founded
2016