Responsibilities:
- Manage daily operations of the Quality Assurance department. Set and communicate priorities to staff. Support daily operations of Quality Control department.
- Ensure continuous improvement and effectiveness of the quality management system work within the quality organization to create strategies improving cycle release times and overall department performance
- Assist in the development and implementation of standards, methods and procedures for testing and inspection of ingredients, components and finished products.
- Manage final review and approval of Master Batch Records, Manufacturing Batch Records, SOPs, Change Control Documentation, Label Change Control, Audit Reports, Product Specifications, R&D Testing Protocols, and Supplier
Qualifications:
- Maintain improve the Company’s quality management system by providing oversight and input into the relevant quality systems and standards including: change control, documentation systems, Quality procedures, standards, and policies, product complaint management, internal and external audit programs and, Material Review Boards, and Vendor Risk Management
- Review and/or approve, non-conformance reports, deviations, OOSs, CAPAs, change control in an efficient manner for adequate and timely closeout of these events
- Manage internal audits with all other departments including but not limited to Operations, Quality, and Engineering
- Support new product testing programs including stability and supplement facts testing and record keeping. Member of the New Product Commercialization team.
- Support and participate in the Company’s project teams and assist with project scheduling to assure that timelines and deadlines are met efficiently and economically.
- Provide regular updates and recommendations to senior management team regarding the status of quality objectives, projects, and goals.
- Hire, manage, and develop Quality Assurance staff and to support the company’s goals and objectives
- Develop and conduct appropriate cGMP 21 CFR part 111 training and compliance for all levels of personnel involved in the manufacturing and release of raw materials and final product.
- Optimize current processes or systems resulting in improved efficiencies and compliance.
- Provide Quality leadership in investigations into non-conforming materials, process deviations, batch failures and other excursions. Facilitate cross departmental Material Review Board Meetings
- Ensure accurate response and documentation of non-conformances and the implementation of appropriate corrective action plans.
- Ensure compliance to Food Safety Modernization Act throughout manufacturing and laboratory procedures and processes.
- Provide leadership on Food Defense and HACCP teams
- Lead the identification and development of quality systems metrics based on quality, manufacturing and other relevant data and input.
- Work across functions such as quality control, manufacturing, R&D, product development, purchasing and engineering to develop holistic understanding of these internal customers’ needs for use in efficient quality department support planning.
- Provide planning and management support across the Quality Department.
- Participate in the ongoing development and maintenance of Quality performance strategy.
- Provide assistance to project management to quality department staff as they liaise with project stakeholders on an ongoing basis to ensure successful results.
- Identify potential operational improvement and opportunities, and support ongoing operational excellence, by:
- Developing benchmarks through Quality and Operation department trends and metrics.
- Manage the reporting of strategic weekly and monthly Quality metrics.
- Develop, review, revise, and approve Standard Operating Procedures (SOPs) as required. Train and ensure that staff adheres to those procedures accordingly.
- Perform other related duties as assigned by Manager.
Education and Experience:
- Bachelor of Science degree in Biology, Chemistry, Food Science or related field
- Minimum of 5 years of experience in a Quality Assurance position
- In-depth knowledge of pharmaceutical and/or dietary supplement cGMPs
- Knowledge of statistical analysis is a must
- Excellent interpersonal and communication (written and verbal) skills
- Strong organizational and time management skills
- Strong proficiency in MS Office (Word, Excel, PowerPoint and Outlook)
- Ability to work independently and collaboratively, while maintaining a sense of timeliness and urgency
- Excellent attention to detail a must
- Understanding of LIMS and quality control analysis is preferred.
Email:
City:
Sebastopol