Sr. QA Auditor - Only EST
Posted 1 week ago by 1756181736
Negotiable
Outside
Remote
USA
Summary: The Sr. QA Auditor role involves planning and conducting independent audits to ensure compliance with regulations and guidelines, primarily in the pharmaceutical sector. The position requires extensive experience in quality assurance and the ability to provide consultation on compliance issues. The role is remote, with a preference for candidates in the EST time zone, and involves collaboration with various stakeholders to promote quality and compliance. The auditor will also manage quality issues and support training initiatives within the organization.
Key Responsibilities:
- Plan, schedule, conduct, report and close audit activities to assess compliance with applicable regulations/guidelines.
- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies.
- Manage quality issues and present educational programs on compliance procedures.
- Review and approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) plans.
- Host audits/inspections and assist in regulatory facility inspections.
- Lead and support QA initiatives/projects for quality and process improvements.
- Assist in training of new Quality Assurance staff.
Key Skills:
- Bachelor's Degree preferred.
- 5 years experience in pharmaceutical or related area, with 3 years in Quality Assurance.
- Knowledge of GXP and quality assurance processes.
- Strong interpersonal, problem-solving, and negotiation skills.
- Effective organization, communication, and team orientation skills.
- Ability to manage multiple projects and work independently.
- Extensive knowledge of pharmaceutical research and regulatory environments.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Detailed Description From Employer:
Title: Sr. QA Auditor
Location: Remote (EST time zone preferred)
Duration: Long Term
Experience: 9 Years of experience
M-F 9-5pm (flexible) and based on audits. EST time zone preferred
Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
Essential Functions
Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
Manage Quality Issues
Present educational programs and provide guidance to operational staff on compliance procedures
Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during simillar QA activities
Provide quality assurance consultancy activities and projects for clients within budget and established timelines
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
Host audits/inspections,Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections
May perform GLP Archivist duties where needed
Manage/oversee quality events updates in eQMS and/or Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
Lead/collaborate/support in QA initiatives/projects for quality, process improvements
Assist in training of new Quality Assurance staff
Qualifications
Bachelor's Degree Pref
5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GXP experience. Equivalent combination of education, training and experience.
Knowledge of word-processing, spreadsheet, and database applications..
Extensive knowledge of pharmaceutical research and development processes and regulatory environments..
Knowledge of quality assurance processes and procedures..
Strong interpersonal skills..
Excellent problem solving, risk analysis and negotiation skills..
Strong training capabilities..
Effective organization, communication, and team orientation skills..
Ability to initiate assigned tasks and to work independently..
Ability to manage multiple projects..
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Title: Sr. QA Auditor
Location: Remote (EST time zone preferred)
Duration: Long Term
Experience: 9 Years of experience
M-F 9-5pm (flexible) and based on audits. EST time zone preferred
Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
Essential Functions
Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
Manage Quality Issues
Present educational programs and provide guidance to operational staff on compliance procedures
Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during simillar QA activities
Provide quality assurance consultancy activities and projects for clients within budget and established timelines
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
Host audits/inspections,Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections
May perform GLP Archivist duties where needed
Manage/oversee quality events updates in eQMS and/or Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
Lead/collaborate/support in QA initiatives/projects for quality, process improvements
Assist in training of new Quality Assurance staff
Qualifications
Bachelor's Degree Pref
5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GXP experience. Equivalent combination of education, training and experience.
Knowledge of word-processing, spreadsheet, and database applications..
Extensive knowledge of pharmaceutical research and development processes and regulatory environments..
Knowledge of quality assurance processes and procedures..
Strong interpersonal skills..
Excellent problem solving, risk analysis and negotiation skills..
Strong training capabilities..
Effective organization, communication, and team orientation skills..
Ability to initiate assigned tasks and to work independently..
Ability to manage multiple projects..
Ability to establish and maintain effective working relationships with coworkers, managers and clients.