Responsibilities:

• 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 Revanches’ 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.

• Attending project meetings and workshops.

• Assure system artifacts are in accordance with Client’s policies, standards, SOPs and meet regulatory standards.

• Serve as QA SME under the supervision of the assigned Clients QSC Leadership.

• Perform duties as assigned by Clients QSC Leadership.

• Assist in the maintenance of the site-based computerized systems.

• Assist in the assessment, review, and approval of change controls, deviations, and CAPA’s.

Requirements:

• 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.

• Excellent verbal, written and interpersonal communication skills.

• Effective time management and interpersonal skills.

• Strong organizational skills, planning skills, and must work effectively within teams.

• Demonstrates good coping skills and analytical problem-solving skills.

Job Type: Contract

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• Day shift
• Monday to Friday
• Weekends as needed

Work setting:

• In-person

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Ability to Commute:

• Newark, CA 94560 (Required)

Ability to Relocate:

• Newark, CA 94560: Relocate before starting work (Required)

Work Location: In person