Job Purpose
Quality System Analyst is responsible for implementation, modification, maintenance, and oversight of Computer System Validation at the site. Responsibilities include initiation of applicable change controls and procedure updates to gain sample throughput efficiencies and ensure integrity of lab data via cGMP and Part 11 compliance.
Report to QA QMS Manager
Key Responsibilities
- Review electronic systems data and related documents to verify compliance with data integrity and 21 CFR Part 11 requirements.
- Draft and execute computer system validation documents including: URS, FRS, Risk Assessment, Design Specification, IQ/OQ/PQ, and Validation Summary Report.
- Ensure proper configuration, validation, and change management of QA systems to comply with regulatory standards (FDA, ISO, GMP, etc.).
- Collaborate with IT and software vendors to resolve system issues, implement updates, and optimize system functionality
- Identify, troubleshoot, and coordinate corrections regarding electronic systems or discrepancies.
- Initiate change controls as necessary to facilitate the implementation of electronic systems.
- Identify areas where training related to data electronic systems is needed and provide appropriate training as required to the site personnel.
- Support Regulatory filing data inquiries and enterprise/site system inspections
- Continually look for process improvement strategies
- Improve site awareness for data reliability related requirements, policies and procedures through reading of SOPs, guidelines and training.
- Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
- Develop technical plans and analyze, identify, plan and manage the scope, and risks required to meet goals of moderately complex to complex projects.
- Develop and update SOPs, work instructions, and training materials for QA systems.
- Provide training and support to site personnel on system functionalities and best practices
- Generate and analyze quality system metrics, dashboards, and reports to support decision-making.
- Monitor system performance and recommend improvements.
- Perform other duties as required to fulfil department and business needs
- Demonstrate validation protocol are drafted and executed effectively.
- Deliver on assigned projects as scheduled.
- Support other departments on related projects as needed.
Skills and Experience
- Familiarity with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).
- Experience with computer system validation
- Experience with change control practices and strategies.
- Familiarity with risk-based thinking or risk-based tools.
- Knowledge of equipment, facility, and utility IQ/OQ/PQ.
- Familiarity with various analytical equipment, techniques, and methodology.
- Excellent oral and written communication
- Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and proofreading skills
- Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills
Qualifications
- Minimum Education: Bachelor's degree in a Life Sciences, Chemistry or Computer Science
- Minimum of 3 years of relevant cGMP experience in the pharmaceutical/biotech industry
Additional Details
Work is performed in a typical office environment and manufacturing areas, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 20% of the time. Safety PPE is required when entering manufacturing and laboratory areas.
location: Pomona, California
job type: Contract
salary: $40 - 45 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
Job Purpose
Quality System Analyst is responsible for implementation, modification, maintenance, and oversight of Computer System Validation at the site. Responsibilities include initiation of applicable change controls and procedure updates to gain sample throughput efficiencies and ensure integrity of lab data via cGMP and Part 11 compliance.
Report to QA QMS Manager
Key Responsibilities
- Review electronic systems data and related documents to verify compliance with data integrity and 21 CFR Part 11 requirements.
- Draft and execute computer system validation documents including: URS, FRS, Risk Assessment, Design Specification, IQ/OQ/PQ, and Validation Summary Report.
- Ensure proper configuration, validation, and change management of QA systems to comply with regulatory standards (FDA, ISO, GMP, etc.).
- Collaborate with IT and software vendors to resolve system issues, implement updates, and optimize system functionality
- Identify, troubleshoot, and coordinate corrections regarding electronic systems or discrepancies.
- Initiate change controls as necessary to facilitate the implementation of electronic systems.
- Identify areas where training related to data electronic systems is needed and provide appropriate training as required to the site personnel.
- Support Regulatory filing data inquiries and enterprise/site system inspections
- Continually look for process improvement strategies
- Improve site awareness for data reliability related requirements, policies and procedures through reading of SOPs, guidelines and training.
- Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
- Develop technical plans and analyze, identify, plan and manage the scope, and risks required to meet goals of moderately complex to complex projects.
- Develop and update SOPs, work instructions, and training materials for QA systems.
- Provide training and support to site personnel on system functionalities and best practices
- Generate and analyze quality system metrics, dashboards, and reports to support decision-making.
- Monitor system performance and recommend improvements.
- Perform other duties as required to fulfil department and business needs
- Demonstrate validation protocol are drafted and executed effectively.
- Deliver on assigned projects as scheduled.
- Support other departments on related projects as needed.
Skills and Experience
- Familiarity with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).
- Experience with computer system validation
- Experience with change control practices and strategies.
- Familiarity with risk-based thinking or risk-based tools.
- Knowledge of equipment, facility, and utility IQ/OQ/PQ.
- Familiarity with various analytical equipment, techniques, and methodology.
- Excellent oral and written communication
- Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and proofreading skills
- Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills
Qualifications
- Minimum Education: Bachelor's degree in a Life Sciences, Chemistry or Computer Science
- Minimum of 3 years of relevant cGMP experience in the pharmaceutical/biotech industry
Additional Details
Work is performed in a typical office environment and manufacturing areas, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 20% of the time. Safety PPE is required when entering manufacturing and laboratory areas.
qualifications:
Job Purpose
Quality System Analyst is responsible for implementation, modification, maintenance, and oversight of Computer System Validation at the site. Responsibilities include initiation of applicable change controls and procedure updates to gain sample throughput efficiencies and ensure integrity of lab data via cGMP and Part 11 compliance.
Report to QA QMS Manager
Key Responsibilities
- Review electronic systems data and related documents to verify compliance with data integrity and 21 CFR Part 11 requirements.
- Draft and execute computer system validation documents including: URS, FRS, Risk Assessment, Design Specification, IQ/OQ/PQ, and Validation Summary Report.
- Ensure proper configuration, validation, and change management of QA systems to comply with regulatory standards (FDA, ISO, GMP, etc.).
- Collaborate with IT and software vendors to resolve system issues, implement updates, and optimize system functionality
- Identify, troubleshoot, and coordinate corrections regarding electronic systems or discrepancies.
- Initiate change controls as necessary to facilitate the implementation of electronic systems.
- Identify areas where training related to data electronic systems is needed and provide appropriate training as required to the site personnel.
- Support Regulatory filing data inquiries and enterprise/site system inspections
- Continually look for process improvement strategies
- Improve site awareness for data reliability related requirements, policies and procedures through reading of SOPs, guidelines and training.
- Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
- Develop technical plans and analyze, identify, plan and manage the scope, and risks required to meet goals of moderately complex to complex projects.
- Develop and update SOPs, work instructions, and training materials for QA systems.
- Provide training and support to site personnel on system functionalities and best practices
- Generate and analyze quality system metrics, dashboards, and reports to support decision-making.
- Monitor system performance and recommend improvements.
- Perform other duties as required to fulfil department and business needs
- Demonstrate validation protocol are drafted and executed effectively.
- Deliver on assigned projects as scheduled.
- Support other departments on related projects as needed.
Skills and Experience
- Familiarity with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).
- Experience with computer system validation
- Experience with change control practices and strategies.
- Familiarity with risk-based thinking or risk-based tools.
- Knowledge of equipment, facility, and utility IQ/OQ/PQ.
- Familiarity with various analytical equipment, techniques, and methodology.
- Excellent oral and written communication
- Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and proofreading skills
- Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills
Qualifications
- Minimum Education: Bachelor's degree in a Life Sciences, Chemistry or Computer Science
- Minimum of 3 years of relevant cGMP experience in the pharmaceutical/biotech industry
Additional Details
Work is performed in a typical office environment and manufacturing areas, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 20% of the time. Safety PPE is required when entering manufacturing and laboratory areas.
skills: Job Purpose
Quality System Analyst is responsible for implementation, modification, maintenance, and oversight of Computer System Validation at the site. Responsibilities include initiation of applicable change controls and procedure updates to gain sample throughput efficiencies and ensure integrity of lab data via cGMP and Part 11 compliance.
Report to QA QMS Manager
Key Responsibilities
- Review electronic systems data and related documents to verify compliance with data integrity and 21 CFR Part 11 requirements.
- Draft and execute computer system validation documents including: URS, FRS, Risk Assessment, Design Specification, IQ/OQ/PQ, and Validation Summary Report.
- Ensure proper configuration, validation, and change management of QA systems to comply with regulatory standards (FDA, ISO, GMP, etc.).
- Collaborate with IT and software vendors to resolve system issues, implement updates, and optimize system functionality
- Identify, troubleshoot, and coordinate corrections regarding electronic systems or discrepancies.
- Initiate change controls as necessary to facilitate the implementation of electronic systems.
- Identify areas where training related to data electronic systems is needed and provide appropriate training as required to the site personnel.
- Support Regulatory filing data inquiries and enterprise/site system inspections
- Continually look for process improvement strategies
- Improve site awareness for data reliability related requirements, policies and procedures through reading of SOPs, guidelines and training.
- Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
- Develop technical plans and analyze, identify, plan and manage the scope, and risks required to meet goals of moderately complex to complex projects.
- Develop and update SOPs, work instructions, and training materials for QA systems.
- Provide training and support to site personnel on system functionalities and best practices
- Generate and analyze quality system metrics, dashboards, and reports to support decision-making.
- Monitor system performance and recommend improvements.
- Perform other duties as required to fulfil department and business needs
- Demonstrate validation protocol are drafted and executed effectively.
- Deliver on assigned projects as scheduled.
- Support other departments on related projects as needed.
Skills and Experience
- Familiarity with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).
- Experience with computer system validation
- Experience with change control practices and strategies.
- Familiarity with risk-based thinking or risk-based tools.
- Knowledge of equipment, facility, and utility IQ/OQ/PQ.
- Familiarity with various analytical equipment, techniques, and methodology.
- Excellent oral and written communication
- Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and proofreading skills
- Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills
Qualifications
- Minimum Education: Bachelor's degree in a Life Sciences, Chemistry or Computer Science
- Minimum of 3 years of relevant cGMP experience in the pharmaceutical/biotech industry
Additional Details
Work is performed in a typical office environment and manufacturing areas, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 20% of the time. Safety PPE is required when entering manufacturing and laboratory areas.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
