Quality Compliance Specialist â€\" Onsite

Ledgent Technology; Alameda (CA); Hybrid; USD 114,616,000 - 126,078,000; Full time

Job summary

Quality Compliance Specialist – Onsite in Canada is seeking an experienced RDQA professional to support GCP/GVP audits, prepare audit materials, and ensure records are accurately entered into the Veeva Quality Vault system.

The role offers hybrid work options with potential for remote consideration based on qualifications; duration is 12 months with possible extension or conversion. Requires 4+ years in biotech/pharma and knowledge of GCP/GVP processes.

Qualifications

• BS/B.Sc in life sciences or STEM with 4+ years in biotech/pharma.
• Alternative: no degree with 6+ years of related experience.
• Experience with GCP or GVP processes for audits.

Responsibilities

• Maintain audit-related records across the program lifecycle.
• Compile data and documents for audits.
• Develop standardized templates based on regulatory requirements.
• Follow up with internal stakeholders regarding the RDQA audit program.
• Input and maintain audit reports in the Veeva Audit Module.
• Track and trend quality metrics for the RDQA program.

Skills

Veeva Quality Vault

Clinical Quality Auditing

GCP/GVP experience

Education

BS/B.Sc in life sciences or STEM

No formal degree with 6+ years experience

Tools

Microsoft Office

Job description

Quality Compliance Specialist – Onsite (JN -092026-430617) Canada

Salary: USD40 - USD44 per hour

Quality Compliance Specialist –Hybrid, open to remote.

Pay Rate: $40 - 44/hr.

Job Title: R&D Quality Assurance Specialist

Location: Candidates able to work in a hybrid model are preferred, though remote candidates may be considered based on qualifications.

Duration: 12 Months

Possibility to extend or convert: Yes

Top Skills:

• 1.Proficiency in Veeva Quality Vault (daily hands-on experience required; Audit Module experience highly preferred)
• Basic knowledge of Clinical Quality Auditing, including audit support and audit documentation activities
• GCP and/or GVP experience within biotech, pharmaceutical, or clinical research environments

JOB DESCRIPTION

SUMMARY/JOB PURPOSE: The R&D Quality Specialist is responsible for providing support to the planning and reporting of GCP/GVP audit activities, including audit preparation, audit closure, audit observation tracking, and records management. As part of continuous improvement initiatives, they will assist in the administration and timely entry of audit reports and related information into the Veeva Quality Vault application. In addition, they will be responsible for ensuring data is migrated to the Veeva audit module.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for maintaining audit-related records throughout the program lifecycle.
• Responsible for obtaining and compiling data relevant documents and data in preparation for the conduct of audits
• Assist in maintaining and developing standardized templates based on regulatory requirements and procedures.
• Conduct follow-up activities with internal stakeholders related to the RDQA audit program.
• Input and maintain audit reports in the Veeva Audit Module.
• Assist in tracking and trending of quality metrics related to the RDQA audit program.

SUPERVISORY RESPONSIBILITIES:

• No supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 4 years of related experience in biotech, pharmaceutical, or related industry.
• Also would consider no formal degree with a minimum of 6 years of related experience in biotech, pharmaceutical, or related industry.

Experience:

• Minimum of 4 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience.
• Must have high attention to detail and excellent organizational skills.
• This position requires a basic knowledge and experience with GCP and / or GVP processes related to the conduct of audits.
• Administrative experience in organizing and maintaining audit related records.
• Proven organizational skills to obtain data across multi-functional groups and present results in a consolidated and clear manner.
• Keeps Management informed of status of assigned projects.

Knowledge/Skills:

• Strong written and oral communication skills.
• Excellent attention to detail and organizational skills.
• Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
• Strong user of Microsoft Office applications.

WORKING CONDITIONS:

Facilities/Alameda with consideration for remote

• Environment: primarily working in an office setting
• Essential physical requirements; sitting, standing, and typing.
• Physical effort/lifting; light - up to 20 pounds