Sr. Quality Documentation Specialist

3 weeks ago


San Francisco, California, United States Michael Page Full time
Equity Competitive comp, great leadership, great hours About Our Client

My client is a leader in the health and wellness industry, dedicated to providing high-quality products that promote well-being and healthy living. Our commitment to excellence is reflected in our innovative product offerings and our adherence to the highest standards of quality and safety.

Job Description

Document Management: Oversee the creation, review, revision, and approval of quality documentation, including Standard Operating Procedures (SOPs), work instructions, batch records, and quality manuals.Compliance: Ensure all documentation meets regulatory requirements, including FDA, ISO, GMP, and other relevant standards in the health and wellness industry.Audit Support: Prepare and maintain documentation for internal and external audits. Serve as a key point of contact during audits to ensure all required documents are accessible and accurate.Continuous Improvement: Identify opportunities to improve documentation processes and implement best practices to enhance the quality management system.Training: Develop and deliver training programs related to quality documentation to ensure all staff are informed and compliant with procedures.Cross-Functional Collaboration: Work closely with Quality Assurance, Regulatory Affairs, Production, and R&D teams to ensure documentation is aligned with company objectives and regulatory standards.Document Control Systems: Manage electronic document management systems (EDMS) and ensure proper version control and accessibility of documents.Risk Management: Identify potential risks in documentation processes and implement corrective and preventive actions (CAPA) as necessary.Reporting: Generate and analyze reports on document management activities and present findings to senior management.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

Education: Bachelor's degree in a related field such as Life Sciences, Quality Assurance, or a similar discipline.Experience: Minimum of 5-7 years of experience in quality documentation within the health and wellness, Food/Bev, Cosmetic, Pharmaceutical, or Med-Device industryKnowledge: Strong understanding of regulatory requirements and industry standards (FDA, ISO, GMP, etc.).Skills:Proficient in document management systems (DMS) and electronic document management systems (EDMS).Excellent attention to detail and organizational skills.Strong communication and interpersonal skills.Ability to manage multiple projects and deadlines in a fast-paced environment.Certifications: Quality-related certifications (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer, SQF Practitioner, PCQI) are a plus.

Not for New York City Applicants.Pursuant to the San Francisco Fair Chance Ordinance, Michael Page will consider for employment qualified applicants with arrest and conviction records.Michael Page will consider for employment qualified applicants with criminal histories in a manner consistent with the Los Angeles Fair Chance Initiative for Hiring Ordinance. What's on Offer EquityCompensation up to $115k BonusHealth, Dental, VisionPTO


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