Job Title: QC Technician/GMP Coordinator

Department: Quality Control

Reports to: Associate Quality Manager

Location: Onsite Fresno CA

FLSA Status: Non-Exempt

Employment Status: Full-Time

Work Schedule: 11:00 a.m. – 7:00 p.m. Monday-Friday willing to work on weekends, day shift, and grave shift as needed.

Pay: $22.11 - $27.47 per hour

Travel: None

Position Summary: Quality products are a foundation to Gusmer's reputation as the Go to Provider in the filtration industry. The QC Technician/GMP Coordinator ensures quality throughout the production process by performing inspections, analyzing data, and maintaining standards while collaborating and communicating with colleagues. Additionally, the position supports document control for the International Organization for Standardization (ISO) Quality Management System (QMS), Good Manufacturing (GMP) compliance, safety protocols, and other controlled documentation.

Essential Functions:

Quality Control Technician

• Collects samples of raw materials, validation, in-process, and finished product. Performs quality control (QC) tests on sample products in a timely and accurate manner per established guidelines and frequencies.

• Conducts in-process audits during each shift to verify adherence to internal procedures and customer specifications.

• Ensures QC support in manufacturing, focusing on environmental monitoring and the verification and validation of cleaning procedures.

• Conducts regular calibration, cleaning, and maintenance of laboratory equipment and instruments, adhering to established protocols and manufacturer guidelines along with managing inventory to facilitate uninterrupted laboratory operation.

• Performs Lumulus Amecbocyte Lysate (LAL) testing as required and performs and conducts microbiological techniques to ensure accurate results.

• Maintains laboratory cleanliness and ensures the proper removal of biohazards to uphold safety standards.

• Complies with all health and safety procedures and policies to ensure workplace safety and regulatory compliance.

• Collects samples and organizes the shipment of samples to external laboratories for testing.

GMP Coordinator

• Supports Gusmer Document Control Coordinators with the maintenance of the QMS documentation to ensure compliance with ISO 9001 requirements along with customer and Gusmer requirements.

• Ensures that controlled copies of documentation are maintained in necessary areas and supports the red-line system as appropriate.

• Supports the facilitation of training as it relates to document changes and new procedure releases.

• Supports the facilitation of Gusmer's GMP program, collaborating with GMP team in plant audits, GMP reports, and program improvements.

• Collaborates with the Food Safety team to perform GMP audits, reporting, and continuous improvement initiatives.

Other Duties.

• Assists in Outside of Specification (OOS) investigations, root cause analysis, and corrective action development.

• Assists Production, Maintenance, and R&D departments when required.

• Provides support at Quality Meetings at both a site and corporate level.

• Assists Supply Chain as directed, with incoming raw material issues/concerns.

• Performs other QC Technician/GMP Coordinator 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

• Highschool Diploma/GED required.

• Analytical Lab or Quality Control Lab experience preferred.

• Food Safety/GMP experience preferred

• ISO 9001 knowledge preferred

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

• Knowledge of analytical and quality control test methods.

• Knowledge of the proper use and preparation of chemicals and reagents.

• Strong working knowledge of various mathematical concepts including fractions, ratios, and proportions.

• Knowledge of Food Safety, Pharmacopeia's and/or Regulatory requirements.

• Knowledge of effective, safe laboratory and experimental procedures.

• Knowledge of Good Manufacturing Practices (GMP) and ISO Quality Management Systems.

• Knowledge of laboratory equipment calibration, maintenance, and operation.

• Skilled in calibrating and maintaining laboratory instruments per established protocols.

• Skilled in organizing and maintaining controlled documentation within a QMS.

• Excellent verbal and written communication skills.

• Excellent organizational skills and attention to detail.

• Ability to self-motivate and work without direct supervision.

• Strong ability to analyze data and results is required.

• Ability to use Microsoft Office, other computer programs, and technology.

• Ability to multi-task and work in an organized manner.

• Ability to work as part of a team in a regulated environment.

• Ability to uphold safety standards and ensure proper handling of hazardous materials.

Physical Requirements

This role involves physical activity typical of a laboratory and office environment . Reasonable accommodations may be made for qualified individuals with disabilities. Modified “light duty” assignments may be available for job-related injuries or illnesses, based on operational needs.

While performing the job duties, the employee may be required to:

• Walk on standard surfaces, sit, and use hands for writing, laboratory, and keyboard work.

• Stand for extended periods of time while performing laboratory work.

• Occasionally lift, carry, and/or push up to 25 lbs.

Sensory Requirements

• Visual acuity sufficient to read a computer screen, printed materials, and performing laboratory work.

• Acute hearing is necessary for phone and in-person communication with fellow employees and other contacts.

Working Conditions

• This position typically functions in a lab and office environment

• Makes routine trips into the warehouse and production areas.

• There will be exposure to moderate noise levels, fumes, dust, chemicals, heat/cold, and allergens especially in the warehouse and production environments.

Work Schedule

• Full time non-exempt position

• Standard hours are 11:00 a.m. – 7:00 p.m. Monday-Friday

• Additional hours may be needed to meet business needs.

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.