Job Description

Improve the health and wellness of thousands of people just by doing your job well? That's exactly what you'd be doing here.

A Quality Assurance Manager with at least 5 years' applicable experience is needed in the Vista, CA area. The Quality Assurance Manager plays a pivotal role in developing, implementing, and maintaining quality assurance systems. This position ensures that all products meet government and company standards while adhering to good manufacturing practices.

Quality Assurance Manager Responsibilities:

• Quality Systems Management: Develop, implement, and maintain quality assurance systems, overseeing batch records review and product attribute inspections both in-line and off-line.
• Compliance and Standards: Ensure finished products meet regulatory and company standards, complying with good manufacturing practices, and making recommendations for corrective actions when necessary.
• Strategic Leadership: Manage short- and long-term objectives, coordinating activities with a focus on cost, methods, and staffing, while providing leadership and development for the quality assurance team.
• Policy Implementation: Embrace and implement company policies, adapting strategic measures that affect operation effectiveness and delivering successful results.
• Metrics and Reporting: Establish meaningful objectives and metrics aligned with company goals. Develop and distribute metrics to support business needs and report on key performance indicators.
• Budget and Supervision: Manage department budgets, schedules, and standards, ensuring alignment with corporate objectives and quality management systems.
• Internal Collaboration: Collaborate with internal departments to resolve quality issues, manage audit programs, and maintain document control systems ensuring compliance.
• Industry Standards and Improvements: Stay current with industry standards and best practices, identifying areas for continuous procedure improvement and managing training requirements.
• Document Control and Audit Management: Lead the audit program, including internal and external audits and maintain oversight of document control systems, compliant with all quality management systems.
• GMP Guidance: Provide guidance and support for GMP quality in production operations.

Quality Assurance Manager Qualifications:

• Bachelor's Degree in a Scientific or Engineering discipline, with a focus in Chemistry, Microbiology, or Biology.
• 5-10 years in quality systems management in the dietary supplements or pharmaceutical industry, with at least 3 years in a supervisory role.
• Professional quality discipline certifications (CQE, CQA, CQM or RAB) are highly desired.
• Strong knowledge of FDA regulations and quality assurance standards such as 21 CFR 111, 110, 117, 210, 211, and ISO9001.
• Excellent verbal and written communication skills, strong interpersonal skills, and proficiency in Microsoft Office Suite.
• Strong negotiation, problem-solving, analytical, and organizational abilities.
• Comprehensive understanding of manufacturing operations and an analytical mindset for data-driven decision-making.

Benefits:

• Competitive Compensation: Earn a salary commensurate with experience, along with potential performance bonuses.
• Health and Wellness: Access to comprehensive health, dental, and vision insurance plans to keep you and your family healthy.
• Retirement Savings: Participate in a robust 401(k) plan with employer matching contributions to help secure your financial future.
• Work-Life Balance: Enjoy generous paid time off, flexible scheduling options, and a supportive work environment.

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