Sr. Quality Systems Specialist

Company: Pendulum---
Location: San Francisco
Posted on: October 12, 2024

Job Description:

About PendulumPendulum is leading a revolution that is occurring around the world to improve physical and mental health by first understanding, then restoring and enhancing the human microbiome.Studies have shown that our microbiome (the bacterial communities in and on our bodies) is linked to everything from metabolism and diabetes to longevity, weight loss, healthy immune systems, cancer prevention, feelings of well-being, inflammatory bowel disease, and even healthy skin. We have just scratched the surface on understanding the impact that our microbiome has on our lives. During early life, we develop a diverse and balanced microbiome that plays a critical role in shaping our long-term health. Over our lives, a combination of diet, lifestyle, antibiotics, and aging can decrease the effectiveness of our microbiome.Pendulum recognized the enormous impact they could have on people's lives if they were able to address the imbalances in the microbiome. To accomplish this, Pendulum created proprietary probiotic pipelines and a unique discovery platform to identify key, novel bacterial strains and the prebiotics that feed them. The company has also built and developed the world's first manufacturing technology to produce bacteria in an anaerobic (oxygen-free) environment at scale.The medical probiotics that Pendulum has formulated have transformed the consumer probiotics market into a new category of therapeutic offerings that deliver the power and efficacy of a pharmaceutical with the safety and accessibility of a natural probiotic. Due to Pendulum's explosive revenue and customer growth over the last two years, the company earned a spot on Forbes Magazine's exclusive "The Next Billion Dollar Startups" list.If you're interested in improving the lives of people globally and you love working in a cross-functional, collaborative, inspiring environment, please continue reading.Position Summary:We are seeking a (Senior) Quality System Specialist to oversee the electronic Quality Management System (eQMS) and the Documentation Control program. This person will adhere to the company's document and SOP procedures while ensuring their accuracy, quality, and integrity. The Quality System Specialist is responsible for the creation, implementation, and revision of new and existing GMP batch production records, supplier qualification documentation, and SOPs. This position partners with cross-functional team members to ensure compliance and operational success through user-focused documentation.This includes quality system responsibility spanning the internal manufacturing and Supply Chain network including our CMO's for fill and finish. We're looking for an exceptional and experienced documentation manager who has outstanding organizational skills, good attention to detail, and can coordinate efforts to address multiple priorities. We're also looking for someone who thrives in a fast-paced, lean, and collaborative environment. They should be both passionate and comfortable working with a very young brand in its early stages of growth.What You'll Do:

• Be the Quality Department's primary owner of the Documentation Control policy and procedures.
• Coordinate, conduct, and maintain the internal audit program and act as the primary SQF Practitioner.
• Review and approve the master batch record templates and technical specifications.
• Generate and report on Quality and Continuous Improvement metrics on an agreed frequency.
• Create training materials for subject matter input and provide appropriate training to the Operations team.
• Organize and coordinate vendor and CMO qualification records for management review and maintain the approved supplier program. Maintain the approved supplier and approved raw materials list and ensure approval of new materials.
• Own quality records (change control, CAPAs, deviations) and deliver to timelines established.
• Review and approve documentation for product release of finished products.
• Autonomously lead and manage projects to implement continuous improvement opportunities.
• Perform weekly quality reviews of the eQMS database by assuring new documents have been entered using appropriate protocols.Knowledge Requirements:
  • Bachelor's degree in a technical field (chemistry, microbiology, food science, biochemistry, chemical engineering, or related discipline) from an accredited college/university.
  • Minimum (6) years quality systems experience and three (3) years related food industry or biotech industry experience. Preference will be given to candidates with experience in probiotics or dietary supplement manufacturing.
  • Familiarity with FSMA, SQF, and 21 CFR part 117 and/or 111 requirements; PCQI (Preventive Controls Qualified Individual), SQF Practitioner certification required.
  • Excellent communication skills, drive, and sense of urgency.
  • Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site-wide objectives. Must have the ability to work as a self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
  • Knowledge and experience writing, revising, and creating cGMP records and SOPs.
  • Hands-on experience facilitating problem-solving and root cause investigations in a cGMP environment - Develops, implements, and assesses solutions for complex problems.
  • Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
  • Knowledge of statistical packages is a plus.
  • Full-time onsite preferred.
    • $90,000-$115,000
    • Medical, Dental, and Vision
    • Commuter Benefits
    • Life & STD Insurance
    • Company match on 401(k)
    • Flexible Time Off (FTO)
    • Equity
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Keywords: Pendulum---, Daly City , Sr. Quality Systems Specialist, Other , San Francisco, California