Specialist, Supplier Quality
Pendulum Therapeutics
Quality Assurance
San Francisco, CA, USA
Posted on Jan 21, 2025
About Pendulum:
Pendulum® 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:
The Supplier Quality Specialist is responsible for the execution of Pendulum supplier quality management programs to ensure suppliers and externally produced products meet company quality requirements and are compliant with relevant regulations. The Supplier Quality Specialist is responsible for maintaining supplier and Contract Manufacturers (CMO) documentation, resolving nonconformances, assisting in conducting supplier / (CMO) quality performance reviews, developing supplier relationships, and auditing new and existing suppliers / CMOs. This role works with Supply Chain to execute sourcing initiatives for new suppliers / CMOs when setting specifications and conducting out of specification investigations, and with Product Development to help commercialize new products. The Supplier Quality Specialist participates in departmental and cross-functional project initiatives.
What You'll Do:
- The duties and responsibilities of this role include, but are not limited to, the following:
- Execute processes for components and product qualification, establishing and maintaining specifications for external raw materials, packaging components, bulk, and finished goods.
- Review and approve supplier / CMO change requests.
- Support investigations of customer complaints.
- Issue supplier / CMO deviation notifications. Review and approve the related corrective action responses.Ensure thorough, accurate, and timely out of specification (OOS) investigations are completed. and appropriate corrective and preventive actions are taken.
- Maintain master data and documentation, including the approved supplier / CMO list, in business information systems
- Facilitate the supplier qualification process and the execution of related quality agreements.
- Participate in continuous improvement efforts for quality, compliance, and efficiency within processes, suppliers / CMOs, and products.
- Build relationships with Supply Chain and key CMOs / suppliers to foster collaboration and continuous improvement in quality and compliance and to mitigate quality risks.
- Monitor supply quality performance with data.
- Maintain cGMP documentation and records to ensure compliance with quality standards.
- Other duties as assigned.
Knowledge Requirements:
- Bachelor’s degree in a technical field (chemistry, microbiology, food science, biochemistry, chemical engineering, or related discipline) from an accredited college/university
- 3-5 years relevant experience in a dietary supplement, pharmaceutical or food manufacturing environment within supplier / CMO quality (Dietary Supplement experience is a plus)
- Working knowledge of FSMA, GFSI schemes, NSF, 21 CFR 111 and 21 CFR 117.
- Ability to partner and collaborate within and across departments to achieve quality requirements and ensure compliance.
- Technical writing skills
- Strong computer skills in business technology platforms
- Excellent oral and written communication skills
- Detailed, analytical and critical thinker with a “can do” attitude
- Strong organizational skills with ability to work independently
Salary & Benefits
- $93,150 - 108,675
- Medical, Dental, and Vision
- Commuter Benefits
- Life & STD Insurance
- Company match on 401 (k)
- Flexible Time Off (FTO)
- Equity