Quality Compliance Specialist â€" Onsite Ledgent Technology

• 3.9 Alameda, CA Job Details Contract $40
• $44 an hour 15 hours ago Qualifications Project reporting Biotechnology Document compliance management Writing skills Audit Reporting Administrative experience Clinical audit and monitoring Pharmaceutical company experience Quality assurance experience within pharmaceutical industry Regulatory readiness in healthcare Productivity software Quality audits Quality control records management Project stakeholder communication File organization Research compliance audit records management Quality assurance experience within healthcare Research compliance quality assurance records management Office record organization Full Job Description 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 All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status.

We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.