Job Title: Quality Assurance Coordinator
Employment Status: Full-Time
Work Schedule: 7 am – 3:30 pm or 8 am – 4:30 pm
Reports to: Quality Manager
Supervisory Responsibilities: No
Pay: $25 to $30 per hour
Position Summary: The Quality Assurance Representative is primarily responsible for maintaining the Quality Management System ISO, safety, GMP, and other controlled company documentation such as Food Safety, and GMP. This position maintains the status of 800-1200 documents with many pending changes at any given time. The Quality Assurance Representative is responsible for working with employees from all sites including, maintenance, production, R&D, quality, engineering, warehousing, management, and other areas as needed.
- Develops, manages, and maintains all Quality Management System documentation to ensure compliance with ISO9001 requirements along with customer and Gusmer requirements.
- Processes Document Change Orders in a timely manner, receiving input from the appropriate personnel and management on documentation, and coordinating necessary training on document changes.
- Ensures that controlled copies of documentation are maintained in necessary areas and manages red-line system as appropriate.
- Coordinates review of all QMS documentation per specified review intervals, including coordination with affected personnel and management to ensure documentation remains accurate. Coordinates follow-up training as appropriate.
- Provides support for customer required audits, including serving as an audit escort and participating in audit responses and follow-ups.
- Coordinates Corporate ISO Consistency efforts including controlling and updating all corporate documentation and the associated training and paperwork.
- Coordinates Corrective (CA) and Preventive Action (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.
- Supports the facilitation of Gusmer’s Good Manufacturing Practice (GMP) program, collaborating with GMP team in plant audits, GMP reports, and program improvements.
- Supports site risk assessment and validation activities as necessary.
- Conducts root cause analysis and helps drive implementation of corrective actions for process related concerns and Nonconforming Material situations. This may include data analysis and testing as part of the investigation.
- Performs final review and release of work orders.
- As lead auditor responsible auditor recruitment/training, developing annual internal audit schedule, audit organization, implementation, and record keeping. Executes the site internal audit program ensuring a robust corrective and preventive action process for all findings, responsible for on time completion of CA and PAs.
- Provides support at Quality Meetings at both a site and corporate level.
- Assists in supporting existing and new product quality initiatives including but not limited to the supporting audits, and product investigations.
- Periodic document review follow-up.
- Supports the Quality Management System.
- Assists with QC Lab functions as needed including First Piece Inspection process.
- Assists Supply Chain as directed, with incoming raw material issues/concerns.
- Performs other Quality Assurance Representative 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
- High School Graduate or equivalent required.
- Bachelor’s Degree in office administration, communications, quality system management, or equivalent experience preferred.
- Three (3) to five (5) years of work experience in ISO9001 certified company or other highly regulated environments with some involvement in QMS.
Knowledge, Skills, and Abilities (KSA’s) Required
- Knowledge of ISO9001 standard and implementation in a manufacturing environment.
- Excellent verbal and written communication skills.
- Ability to multi-task and work in an organized manner.
- Ability to follow verbal and written instructions.
- Ability to work well with others to ensure success of system.
- Ability to take requirements and concepts and convert to written instructions.
- Excellent organizational skills and attention to detail.
- Intermediate/Advanced Microsoft Office word processing and spreadsheet knowledge.
- Ability to use Microsoft Office, other computer programs, and technology.
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 walk on normal surfaces and sit; use hands for writing and keyboarding. The employee is occasionally required to lift, carry, and/or push up to 25 lbs., stand, and walk on uneven surfaces. Specific vision abilities required by this job include visual acuity sufficient to read a computer screen and paper documents. Acute hearing is necessary for phone and in-person communication with fellow employees and other contacts.
This position typically functions in a combination of lab, office, and production/warehouse areas. There is some travel as needed to other sites as needed. There will be exposure to moderate noise levels, fumes, dust, chemicals, heat/cold, and allergens especially in the warehouse, production, and travel environments.
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.