Specialist Quality Systems and Compliance

California All, CA 94560-1152

Job Type: Scientific Job Number: JN -052024-32492 Region: California All

Job Description

R&D Partners is seeking to hire a Specialist Quality Systems and Compliance IV in Newark, CA.

Your main responsibilities as a Specialist Quality Systems and Compliance IV:

Assist Quality Systems and Compliance Team in project work for assigned computer systems assessment, implementation and enhancement projects and system rollout.

Serve as QA Lead on systems implementation projects, quality records, and steady state activities.

Provide support to ensure system qualification/validation activities are planned, executed, and finalized in compliance with regulatory requirements and company s policies and SOPs.

Support Data Integrity program by serving as QA Lead on gap assessments, risk assessments and remediation plans.

Develop SOPs, review and approve Validation strategy, plans, protocols, procedures.

What we are looking for in a Specialist Quality Systems and Compliance IV:

BA/BS or equivalent combination of related education and experience

Comprehensive expertise and working knowledge of 21 CFR Parts 11, 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents

Extensive knowledge and competence in core Quality processes, including change control, training, deviation, CAPA, risk management, and vendor management.

Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles.

Experience in providing oversight in implementing and maintaining GXP computer systems in a validated state.

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

Medical insurance PPO, HMO & HSA

Dental & Vision insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Expense reimbursement

Online timecard approval

Pay Scale:

$136,830 $171,052 (Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

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