JOB SUMMARY:

Charged with updating and maintaining a systems to assure that all products manufactured by the organization meet customer specifications and achieve superior quality and reliability levels.

All Biowest USA employees are required to cultivate an environment of quality & compliance. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. All Management level employees must ensure employees within their areas of oversight are trained appropriately.

ESSENTIAL FUNCTIONS:

• Works with the Management Team to design, implement, and maintain a ISO certifications along with quality system that achieves customer and company demands.
• Oversee QA/QC program to ensure conformity of purchased material and final products to quality standards.
• Validate and implement new processes and equipment, including developing infrastructure and assisting in development of new processes, protocols, and documentation in area of oversight.
• Perform root-cause analysis and implementation of corrective action for process-related concerns.
• Oversee the evaluation of finished product for quality and reliability.
• Interpret results of and/or utilize testing and validation techniques related to animal sera and related products.
• Work with manufacturing personnel to identify and prioritize testing and release requirements.
• Ensure testing is performed as needed in the laboratory to maintain timelines for product disposition.
• Develop and maintain an approved supplier quality index to assure that only high-quality vendors are retained.
• Meet with vendors, customers, quality representatives, and company personnel to discuss and resolve quality problems as required.
• Prepare all necessary quality documents and reports as required by customers, QA department needs, and staff personnel.
• Manage training files and programs and conduct GMP training as required.
• Develop and maintains audit schedules and conducts audits to ensure compliance with quality procedures and expectations.
• Troubleshoot logistical, technical and personnel problems as they arise in area of oversight.
• Maintain awareness of the business context, including budgetary control issues.
• Lead and direct the work of others.
• Ability to develop methods and tests for the following: Endotoxin, Hemoglobin and GGT

ADDITIONAL RESPONSIBILITIES:

Develop and Oversee the Quality Assurance and Quality Control departments and, as applicable, direct QA/QC personnel. Will be required to take the lead during customer audits, must be confident during the audits.

EDUCATION AND EXPERIENCE:

A bachelor's degree or greater in a related area is required. A minimum of 7-10 years of experience in the field or in a related area is preferred. Some quality assurance practices as they apply to individual unique products can be learned during on-the-job training, but overall capability in this discipline must be previously demonstrated. Experience in a Quality Control department utilizing plate readers, spectrophotometers, and chemistry analyzers is required. Ability to interpret data is also required.

RELATIONSHIPS AND CONTACTS:

1. Reports directly to the President/CEO and is responsible for product quality.

2. Essential contact with all levels of customer organizations.

Job Type: Full-time

Pay: From $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Weekly day range:

• Monday to Friday
• Weekends as needed

Work Location: In person