Quality Assurance Specialist II

SUMMARY OF POSITION:

The Quality Assurance Specialist assists in assuring company standards are maintained and product requirements are met. The Quality Assurance Specialist reports to the Manager of Quality Assurance and will consult management to document and resolve quality, production, and efficiency problems. This individual functions as an information source to production technicians and various company departments when special and critical quality issues occur.

KEY DUTIES AND RESPONSIBILITIES:

• Review of production records, finished product inspection, release documentation generation, and finished product release.
• Author, update, and formally review SOPs, specifications, batch records, and other quality documentation to adhere to internal and client regulatory requirements.
• Document and investigate issues and assist in determining root cause and action plans.
• Assist with internal and external audits and approved supplier program
• Maintain electronic databases, documentation filing, and retain storage
• Perform line/system/product inspection and swabbing for sample collection.
• Issue batch records, labels, and supporting documentation to production staff.
• Communicate and collaborate with other departments
• Educate and instruct plant personnel in recommended quality control testing, equipment sanitation and general sanitation and housekeeping practices.
• Work in conjunction with QA/QC Leadership to assist with assigned projects
• Other duties as assigned.

The above statements are intended to describe the general nature and level of work being performed by employees in this position. This is not intended to be an exhaustive list of all responsibilities.

Requirements

EXPERIENCE REQUIRED:

5-9 years of experience in quality, laboratory, or production facility.

Forklift certification a plus.

EDUCATION/LICENSES/CERTIFICATION/FORMALTRAINING:

Associates degree in STEM or equivalent field or four years work experience in a quality assurance related field.

ESSENTIAL ABILITIES:

• Excellent Math and Writing skills
• Attention to Details
• Technical Capacity: Microsoft Suite, Email, electronic systems (QMS, ERP)
• Discretion
• Problem Solving/Analysis
• Decision Making
• Communication Proficiency: verbal and written
• Collaboration Skills
• Performance Management
• Release Decisions