Quality Assurance Manager

Job Description

Hyacinth Proteins seeks highly independent, entrepreneurial individual who will assist in developing a commercialization-focused, industrial-scale production operation supported by novel protein research.

The Quality Assurance Manager will join a growing team in this early-stage company to apply expertise in quality assurance and analysis of dairy-derived proteins. They will lead the development of the Quality Assurance department including its staffing, growth, and finalization of Hyacinth Proteins industrial procedures.

The Quality Assurance Manager will ensure consistent production of safe, ultra-high-quality product by following corporate and regulatory guidelines. As facilities expand, the Quality Assurance Manager will assist in structuring the needed quality systems, protocols, and metrics to ensure product quality. The position is located in Twin Falls, ID and will report to the Vice President of Protein Manufacturing.

Specific responsibilities include:

• Be the strongest internal advocate for product safety and quality

• Perform all in-process and final product evaluation including compositional analysis, biochemical testing and microbial analysis

• Manage and complete all required documentation related to production, compliance, audits and analytical analyses (COA and SDS)

• Manage, audit and perform microbial sanitation testing throughout the production facility as required by ISO 7, ISO 9001 standards to include water quality, surfaces and air sampling

• Manage and perform employee cGMP and QA training as necessary and advise on further team expansion needs

• Manage and assure the maintenance of all analytical lab equipment

• Manage and coordinate all third-party testing and sample shipments

• Manage and coordinate all inbound shipments of raw materials and confirm that they meet the receiving specifications set forth to meet FDA standards

• Manage and coordinate all outbound shipments of products and confirm that they meet the specifications set forth to meet FDA standards and those of the customer

• Manage and ensure that Hazard Analysis Critical Control Point (HACCP), Hazard Analysis & Risk-based Preventive Controls (HARPC), Sanitation Standard Operating Procedures (SSOPs), formulations, & finished product consistently meet specifications

• Manage GMP regulatory compliance (including facility pest control) and safety programs and serve as liaison for inspections

• Must be mobile and capable of traversing stairs while lifting objects up to 40lbs in weight

• Must be comfortable wearing IOS7 cleanroom garments

• Must be able perform the essential job functions of this position with or without reasonable accommodation

Qualifications

· B.S. or higher with experience in microbiology, biology or chemistry preferred

o When possessing a Food Science degree, further validation of significant experience in an analytical laboratory setting will be required

· 5 years’ experience working in supervisory role in quality assurance, preferably in a biopharmaceutical setting

· Experience with the following compliance processes and regulators:

o Hazard Analysis and Critical Control Points (HACCP)

o United States Department of Agriculture (USDA)

o Food and Drug Administration (FDA)

§ Preferred experience with 21CFR and/or Labguru or a similar electronic laboratory notebook used in a regulated production setting

o Occupational Safety and Health Administration (OSHA)

o Good Manufacturing Practice (GMP)

• Experience with biochemical and biophysical lab equipment or related such as, but not limited to ELISA, DSC, ITC, LC/MS, Capillary electrophoresis, SDS-PAGE, Microbial assays, Spectrophotometry, Rapid Microbial Detection or HPLC
• Strong analytical and critical thinking skills to proactively identify and define problems, collect data, establish facts and draw valid conclusions through reporting
• Ability to apply statistical process control concepts and generally evaluate product quality during processing
• Ability to comprehend, analyze and interpret scientific and technical journals, financial reports and compliance documents which possess legal language
• Ability to communicate effectively in written and oral form with regulatory inspectors and other officials

Job Type: Full-time

Pay: $71,170.00 - $75,368.00 per year

Benefits:

• Dental insurance
• Flexible schedule
• Health insurance
• Health savings account
• Paid time off
• Professional development assistance
• Relocation assistance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Commute:

• Salt Lake City, UT (Required)

Ability to Relocate:

• Salt Lake City, UT: Relocate before starting work (Required)

Work Location: In person

Salary : $71,170 - $75,368