Quality System Supervisor

BEST FORMULATIONS LLC•Industry, CA

86d•$85,000 - $104,000•Onsite

About The Position

We are a trusted partner to our customers when it comes to innovation and have one of the strongest R&D, product formulation and technical teams in the industry. We are recognized as the leader in plant-based softgel innovation and our ability to encapsulate difficult formulas. We seek out innovation across our entire business and pass that knowledge and expertise to our customers. As a Quality System Supervisor,

Requirements

BA/BS in Science or related with at least 5 years pharmaceutical, nutraceutical, nutricional and/or related industry in a quality management role or an advanced degree with +2 year of experience;
Experience working in a manufacturing environment;
Experience working in a fast-paced work environment;
or Any combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successfully perform the job.

Responsibilities

Promote a strong quality culture throughout the site by supporting cross-functionally with other departments.
Assist in managing and improving quality systems, processes, procedures and protocols for compliance.
Support compliance risk assessments including HACCP and Food Defense.
Help monitor and provide input on equipment validation protocols, including cGMP compliance, regulatory issues and validation strategy.
Assist in coordinating validation activities to ensure compliance and timely completion.
Work with quality management in the development and maintenance of quality management systems.
Work with quality management to track Quality performance to key performance indicators (KPI).
Coordinate with manufacturing to resolve quality issues and drive quality improvement throughout the facility.
Support all customer quality affairs, assisting with documentation, questionnaires, and agreements.
Perform trending on Quality System; provide evaluation to Senior Management.
Participate in and help lead projects designated by upper management.
Recognize trends, deviations, problems and promptly report them to management.
Write and review of Standard Operation Procedures and Quality Operational Procedures.
Perform trend analysis to monitor process, customer complaints and other quality parameters.
Conduct investigations and root cause analysis to identify root causes for problems and complaints.
Recommend and implement corrective action to prevent recurrence in collaboration with Quality Systems.
Participate in Internal Quality Audits and provide primary support, planning, and hosting of internal and external, and other regulatory agency inspections ensuring compliance to procedures and regulations.
Ensures that the CAPAs resulting from internal and external audits are assigned a CAPA owner and closed out in a timely manner.
Maintain a working knowledge of government and industry Quality standards.
Ensures through subordinates that the CAPA system are effective and that CAPAs are monitored for timely close out.
Ensure the labels for drug and/or nutritional product are in compliance.
Support in-house cGMP training and awareness programs for Quality Operation staff and other employees as needed.
Ensure manufacturing of the products are executed as per cGMP guidelines and Best Formulations written Standard Operation Procedures.
Follow established department SOP's, cGMP regulations, and batch record instructions.
Complies with all Company policies and procedures, including safety rules and regulations.
Maintains a safe work environment and operates in a safe manner.
Perform other related job duties related to the job, as assigned by management.