Turn Job Alerts On
Actalent
San Mateo,CA
New
Description
Job Title: QA Records Management Specialist Job Description The QA Records Management Specialist applies established policies and procedures to manage physical and electronic records in a GxP-regulated environment. This role classifies, codes, processes, stores, retrieves, preserves, and destroys records in accordance with defined systems and retention policies. The specialist works closely with stakeholders across the organization to support the full lifecycle of information, ensuring compliance with legal, regulatory, and operational requirements aswell as standard operating procedures. Responsibilities
- Support the records management program to ensure that the maintenance, retrieval, inventory, retention, and destruction of all records align with the organization's records retention policy.
- Organize and process incoming records and records requests promptly and accurately.
- Ensure the correct and timely input of database entries and verify both personal work and the work of others for accuracy and completeness.
- Collaborate with internal customers to ensure the correct and timely implementation of records-related requests.
- Coordinate and perform scanning activities to convert physical records to electronic format, ensuring projects are completed accurately and on schedule.
- File and maintain controlled documents and records accurately in accordance with established procedures.
- Maintain an organized inventory, directory, or index of all records within the validated records management system.
- Advise stakeholders on current industry best practices and professional trends in records management.
- Promote the organization's objective to reduce the use and creation of physical hardcopy files by encouraging digital solutions.
- Conduct research and retrieve information and documents in response to internal requests.
- Prioritize and accomplish multiple tasks in a fast-paced, deadline-driven, and detail-oriented environment.
- Collaborate with departments to determine and implement special records management and retention requirements.
- Stay current on basic compliance requirements relevant to the records management function.
- Provide instruction or assistance to junior staff in a lead capacity when needed.
- Notify management of compliance questions, concerns, or potential issues related to records and documentation.
- Participate in training related to records management, compliance, and other topics affecting the role.
- Audit records or assist auditors during records audits to ensure adherence to policies and regulations.
- Support the maintenance and organization of the secured archival room.
- Provide additional support and assistance on tasks and projects as directed by management.
- Minimum of a high school diploma.
- 1-4 years of relevant experience in record retention, information governance, records management, data governance, knowledge management, or library work in a regulated environment, preferably in pharmaceutical, biotechnology, medical device, clinical trials, financial, or other highly regulated industries.
- Experience working with hardcopy regulated and controlled documents and records in a regulated environment.
- Experience categorizing, organizing, and archiving regulated documents, including the ability to propose solutions and solve problems when dealing with large volumes of records.
- Experience working with electronic records systems.
- Proficiency with Microsoft Word, including the ability to take electronic requests and create Word tables.
- Ability to analyze data and interpret information to improve the management of product records.
- Ability to apply and clearly explain moderately complex policies and procedures related to records management.
- Strong attention to detail and accuracy in handling, entering, and verifying records.
- Ability to assist staff in records management procedures and the use of process software.
- Ability to exercise discretion and maintain the confidentiality of records and sensitive information.
- Ability to work effectively both independently and as part of a team.
- Knowledge of legal aspects of records retention and disposal.
- Knowledge of techniques for providing a high level of customer service when dealing with internal stakeholders.
- Experience in a GxP-regulated environment such as pharmaceutical, biotechnology, or medical device organizations.
- Demonstrated ability to acquire new knowledge and competencies quickly through experience, study, or training.
- Ability to challenge assumptions, explore new approaches, and propose innovative solutions to records management challenges.
- Strong communication skills, with the ability to share and synthesize information, influence decisions, and guide stakeholders.
- Ability to tailor communication and influence style to different audiences and needs.
- Ability to create or identify effective solutions to records-related problems and plan for their implementation.
- Digital mindset, with the ambition and agility to work digitally and pursue digital opportunities to help meet organizational goals.
- Ability to establish, maintain, and foster positive and effective working relationships across departments.
- Ability to support team success by sharing resources and knowledge to execute shared responsibilities and goals.
Turn Job Alerts On
Actalent
San Mateo,CA
New
Description
Job Title: QA Records Management Specialist Job Description The QA Records Management Specialist applies established policies and procedures to manage physical and electronic records in a GxP-regulated environment. This role classifies, codes, processes, stores, retrieves, preserves, and destroys records in accordance with defined systems and retention policies. The specialist works closely with stakeholders across the organization to support the full lifecycle of information, ensuring compliance with legal, regulatory, and operational requirements aswell as standard operating procedures. Responsibilities
- Support the records management program to ensure that the maintenance, retrieval, inventory, retention, and destruction of all records align with the organization's records retention policy.
- Organize and process incoming records and records requests promptly and accurately.
- Ensure the correct and timely input of database entries and verify both personal work and the work of others for accuracy and completeness.
- Collaborate with internal customers to ensure the correct and timely implementation of records-related requests.
- Coordinate and perform scanning activities to convert physical records to electronic format, ensuring projects are completed accurately and on schedule.
- File and maintain controlled documents and records accurately in accordance with established procedures.
- Maintain an organized inventory, directory, or index of all records within the validated records management system.
- Advise stakeholders on current industry best practices and professional trends in records management.
- Promote the organization's objective to reduce the use and creation of physical hardcopy files by encouraging digital solutions.
- Conduct research and retrieve information and documents in response to internal requests.
- Prioritize and accomplish multiple tasks in a fast-paced, deadline-driven, and detail-oriented environment.
- Collaborate with departments to determine and implement special records management and retention requirements.
- Stay current on basic compliance requirements relevant to the records management function.
- Provide instruction or assistance to junior staff in a lead capacity when needed.
- Notify management of compliance questions, concerns, or potential issues related to records and documentation.
- Participate in training related to records management, compliance, and other topics affecting the role.
- Audit records or assist auditors during records audits to ensure adherence to policies and regulations.
- Support the maintenance and organization of the secured archival room.
- Provide additional support and assistance on tasks and projects as directed by management.
- Minimum of a high school diploma.
- 1-4 years of relevant experience in record retention, information governance, records management, data governance, knowledge management, or library work in a regulated environment, preferably in pharmaceutical, biotechnology, medical device, clinical trials, financial, or other highly regulated industries.
- Experience working with hardcopy regulated and controlled documents and records in a regulated environment.
- Experience categorizing, organizing, and archiving regulated documents, including the ability to propose solutions and solve problems when dealing with large volumes of records.
- Experience working with electronic records systems.
- Proficiency with Microsoft Word, including the ability to take electronic requests and create Word tables.
- Ability to analyze data and interpret information to improve the management of product records.
- Ability to apply and clearly explain moderately complex policies and procedures related to records management.
- Strong attention to detail and accuracy in handling, entering, and verifying records.
- Ability to assist staff in records management procedures and the use of process software.
- Ability to exercise discretion and maintain the confidentiality of records and sensitive information.
- Ability to work effectively both independently and as part of a team.
- Knowledge of legal aspects of records retention and disposal.
- Knowledge of techniques for providing a high level of customer service when dealing with internal stakeholders.
- Experience in a GxP-regulated environment such as pharmaceutical, biotechnology, or medical device organizations.
- Demonstrated ability to acquire new knowledge and competencies quickly through experience, study, or training.
- Ability to challenge assumptions, explore new approaches, and propose innovative solutions to records management challenges.
- Strong communication skills, with the ability to share and synthesize information, influence decisions, and guide stakeholders.
- Ability to tailor communication and influence style to different audiences and needs.
- Ability to create or identify effective solutions to records-related problems and plan for their implementation.
- Digital mindset, with the ambition and agility to work digitally and pursue digital opportunities to help meet organizational goals.
- Ability to establish, maintain, and foster positive and effective working relationships across departments.
- Ability to support team success by sharing resources and knowledge to execute shared responsibilities and goals.
Smart Searches
Related Job Titles To Medical Technologist
