Penumbra
QC Training Specialist II - Swing shift
Penumbra, Alameda, California, United States, 94501
The Quality Control Training Specialist II will develop and execute training programs to support the stability and growth of our Quality Inspection environments.
Perform tasks as assigned to increase the knowledge and understanding of GMP and Quality processes, which include, but are not limited to: New Inspector Training, Train the Trainer, Lead Training and Quality System (QSR) initiatives, etc.
Develop and maintain current programs and materials, and independently develop new programs as future needs are identified from cross-functional sources (e.g. SMEs, inspectors, supervisors, production).
Work independently to solve problems and actively participate in departmental process improvements linked to training.
Specific Duties and Responsibilities
Develop, revise & maintain current training programs and materials (e.g., PowerPoint presentations, assessments, certification tests, worksheets, job aids, etc.) with minimal guidance from management.
Train and test personnel for comprehension in inspecting medical devices per Penumbra’s Quality System.
Provide required training on SOPs, ECOs, WIs, MQIs and Quality System requirements to inspectors.
Provide training in other Penumbra manufacturing locations when needed.
Respond to training requests identified by supervisors and managers.
Drive resolution of process and/or documentation issues including origination and implementation of change requests.
Responsible for completion of personnel training records and training record monitoring and maintenance such as scanning, filing, matrices.
Resolve and respond to training issues and questions from throughout the Quality organization.
Recommend solutions for systemic training related issues.
Communicate effectively with all levels of the organization to determine training needs.
Design, develop and update training content as needed to ensure optimal learning experience and retention.
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
Ensure other members of the department follow the QMS, regulations, standards, and procedures.
Perform other work-related duties as assigned.
Position Qualifications
Bachelor’s degree required with 3+ years of quality systems experience in a regulated device or pharmaceutical environment, plus 3+ years of learning and development or training experience, ideally acquired in the medical device, pharmaceutical or biotechnology industries, or an equivalent combination of education and experience in an equivalent industry.
Strong project and process management skills.
Strong verbal, written and interpersonal communication skills.
Strong presentation skills.
Ability to independently develop content (PowerPoint) and simplify complex processes.
Basic math skills are required, as well as proficiency with Microsoft Word, Excel, Access, and Power Point.
Strong attention to detail, organization, and teamwork skills.
Basic knowledge of GMP/QSR requirements.
Ability to work swing shift hours of: 4 pm to 12:30 am.
Working Conditions
General office, production, and cleanroom environments.
Willingness and ability to work on site.
Potential exposure to blood-borne pathogens.
Requires some lifting and moving of up to 25 pounds.
Must be able to move between buildings and floors.
Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
Must be able to read, prepare emails, and produce documents and spreadsheets.
Must be able to move within the office and access file cabinets or supplies, as needed.
Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Annual Base Salary Range: $72,817 - $103,644
We offer a competitive compensation package plus a benefits and equity program, when applicable.
Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
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Perform tasks as assigned to increase the knowledge and understanding of GMP and Quality processes, which include, but are not limited to: New Inspector Training, Train the Trainer, Lead Training and Quality System (QSR) initiatives, etc.
Develop and maintain current programs and materials, and independently develop new programs as future needs are identified from cross-functional sources (e.g. SMEs, inspectors, supervisors, production).
Work independently to solve problems and actively participate in departmental process improvements linked to training.
Specific Duties and Responsibilities
Develop, revise & maintain current training programs and materials (e.g., PowerPoint presentations, assessments, certification tests, worksheets, job aids, etc.) with minimal guidance from management.
Train and test personnel for comprehension in inspecting medical devices per Penumbra’s Quality System.
Provide required training on SOPs, ECOs, WIs, MQIs and Quality System requirements to inspectors.
Provide training in other Penumbra manufacturing locations when needed.
Respond to training requests identified by supervisors and managers.
Drive resolution of process and/or documentation issues including origination and implementation of change requests.
Responsible for completion of personnel training records and training record monitoring and maintenance such as scanning, filing, matrices.
Resolve and respond to training issues and questions from throughout the Quality organization.
Recommend solutions for systemic training related issues.
Communicate effectively with all levels of the organization to determine training needs.
Design, develop and update training content as needed to ensure optimal learning experience and retention.
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
Ensure other members of the department follow the QMS, regulations, standards, and procedures.
Perform other work-related duties as assigned.
Position Qualifications
Bachelor’s degree required with 3+ years of quality systems experience in a regulated device or pharmaceutical environment, plus 3+ years of learning and development or training experience, ideally acquired in the medical device, pharmaceutical or biotechnology industries, or an equivalent combination of education and experience in an equivalent industry.
Strong project and process management skills.
Strong verbal, written and interpersonal communication skills.
Strong presentation skills.
Ability to independently develop content (PowerPoint) and simplify complex processes.
Basic math skills are required, as well as proficiency with Microsoft Word, Excel, Access, and Power Point.
Strong attention to detail, organization, and teamwork skills.
Basic knowledge of GMP/QSR requirements.
Ability to work swing shift hours of: 4 pm to 12:30 am.
Working Conditions
General office, production, and cleanroom environments.
Willingness and ability to work on site.
Potential exposure to blood-borne pathogens.
Requires some lifting and moving of up to 25 pounds.
Must be able to move between buildings and floors.
Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
Must be able to read, prepare emails, and produce documents and spreadsheets.
Must be able to move within the office and access file cabinets or supplies, as needed.
Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Annual Base Salary Range: $72,817 - $103,644
We offer a competitive compensation package plus a benefits and equity program, when applicable.
Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
#J-18808-Ljbffr