Essential Functions

• Ensure compliance to Regulatory, Customer, and quality systems requirements.

• Direct all activities of Laboratory Managers and Quality Department personnel.

• Act as primary quality contact with new and existing customers to ensure products are manufactured to established standards.

• Communicate to production management the status of the quality system as it relates to the site and all deficiencies to the systems

• Make disposition on all raw materials, components and finished products.

• Manage and coordinate the investigation of Out of Specification results for analytical and microbiological tests (non[1]SSR sites only).

• Develop and maintain Master Product Records for all products manufactured at the facility.

• Conduct routine audits of department results and records to ensure regulatory, customer, and company policies and procedures are adhered to.

• Develop, update, and implement new and existing policies and procedures.

• Submit all required reports in a timely manner.

• Assume special projects under the direction of the Vice President of Quality and Director of Quality Assurance.

Requirements

• Requires a bachelor’s degree with a strong emphasis in a natural science.

• Minimum of 5 years of Management / Supervisory experience in a regulated environment.

• Prior experience (5 years) in Quality Assurance or Quality Control.

• Requires the ability to read, analyze, and interpret business information, journals, technical procedures, or governmental regulations.

• Must have excellent communication skills (written and verbal) to write reports and findings and present to all levels of management in a clear and concise manner.

• Strong project management skills.

• Strong mathematical concepts such as probability and statistical inference as well as the ability to apply such concepts such as fractions, percentages, ratios, and proportions to practical situations.

• PC proficiency to include Microsoft Office (Word, Excel, Access, PowerPoint, Sharepoint, etc.) along with Google Suite, Outlook, statistical analysis software, and contract management software.

• Position comes with full medical, dental, vision, & 401K benefits.

Pay Details: $70,000.00 to $90,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance