Job Title: Quality Assurance Specialist
Employment Status: Full-Time
Classification: Non-Exempt
Work Schedule: 8:00 a.m. – 4:30 p.m. Monday – Friday; ability to work overtime and weekends as needed.
Reports to: Quality Manager
Supervisory Responsibilities: No
Pay: $23.00 to $26.00/hour
Position Summary: The Quality Assurance Specialist is primarily responsible for assisting in maintaining the Quality Management System on a local level. This includes, but is not limited to, assisting with product quality investigations/corrective and preventative actions, customer complaints, supporting audits, and other responsibilities as assigned in support of the Quality Management System. This position will also function as a backup for the local Hickory Quality Representative.

Essential Functions:

• Coordinates Corrective and Preventive Action (CA/PA) efforts, including CA/PA initiation and assignment, follow-up activities with responsible managers, tracking for quarterly Management Review, and verifying effectiveness of actions taken.
• Collaborates with other functions in the organization on change control, risk assessments, and validation activities. Works with customers on protocol and report content, driving consistency.
• Coordinate local Internal Audit program and associated follow-ups.
• Coordinate monthly Good Manufacturing Program (GMP) inspection and associated follow-ups.
• Support the Good Manufacturing Practice (GMP) program through collaboration with the GMP team during plant audits, preparing GMP reports, and implementing program improvements.
• Conduct root cause analysis and coordinate implementation of corrective actions for process related concerns and Nonconforming Material situations. This may include data analysis and testing as part of the investigation.

Other Duties

• Support the document control and training as needed.
• Perform final Quality Assurance review and release of finished product as needed
• Provide support at Quality Council at both a site and corporate level.
• Assists QC Lab functions as needed
• Assists Supply Chain as directed, with incoming raw material issues/concerns.
• Assists with investigation testing as needed, including L&E or device testing.
• Performs other Quality Department duties as assigned.

This is not meant to be a comprehensive listing of activities, duties, and responsibilities. These items may change, or new items may be assigned with or without notice.

Experience and Education Requirements

• Bachelor’s Degree in a life sciences or equivalent experience preferred.
• Three years of work experience in ISO9001 certified company or other highly regulated environments with some involvement in QMS.
• Six-sigma training preferred

Knowledge, Skills, and Abilities (KSA’s) Required

• Knowledge of ISO9001 standard and implementation in a manufacturing environment.
• Ability to multi-task and handle variety of projects and assignments daily.
• Ability to work well with others to ensure success of system.
• Ability to take requirements and concepts and convert to written instructions.
• Intermediate/Advanced Microsoft Office word processing and spreadsheet knowledge
• Ability to use Microsoft Office, other computer programs, and technology.

Physical Requirements
The physical demands listed are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Modified “light duty” restrictions may be arranged as needed and when available for job-related injuries or illnesses.
While performing the duties of this job, the employee is regularly required to sit, walk, and stand; lift/carry/push/pull under 10 pounds; use hands repetitively for writing, keyboarding, and grasping/holding. The employee is occasionally required to lift/carry/push/pull up to 20 pounds; twist/turn; reach outward and over shoulders, and bend and squat.
Specific vision abilities required by this job includes close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Acute hearing is necessary for telephone and in-person communication with customers and fellow employees, and visual acuity sufficient to read a computer screen and paper documents.
Working Conditions
This position typically functions in a combination of an office and plant environment; there will be exposure to moderate noise levels, fumes, dust, chemicals, heat/cold and allergens especially in plant/warehouse environment.
EEO Policy Statement:
Gusmer Enterprises, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Gusmer will also consider requests for reasonable accommodations made by applicants and employees on an individualized basis, including those based on disabilities and sincerely held religious beliefs, where such accommodations do not impose an undue burden on the business. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training

Essential Functions:

• Coordinates Corrective and Preventive Action (CA/PA) efforts, including CA/PA initiation and assignment, follow-up activities with responsible managers, tracking for quarterly Management Review, and verifying effectiveness of actions taken.
• Collaborates with other functions in the organization on change control, risk assessments, and validation activities. Works with customers on protocol and report content, driving consistency.
• Coordinate local Internal Audit program and associated follow-ups.
• Coordinate monthly Good Manufacturing Program (GMP) inspection and associated follow-ups.
• Support the Good Manufacturing Practice (GMP) program through collaboration with the GMP team during plant audits, preparing GMP reports, and implementing program improvements.
• Conduct root cause analysis and coordinate implementation of corrective actions for process related concerns and Nonconforming Material situations. This may include data analysis and testing as part of the investigation

Other Duties

• Support the document control and training as needed.
• Perform final Quality Assurance review and release of finished product as needed
• Provide support at Quality Council at both a site and corporate level.
• Assists QC Lab functions as needed
• Assists Supply Chain as directed, with incoming raw material issues/concerns.
• Assists with investigation testing as needed, including L&E or device testing.
• Performs other Quality Department duties as assigned