Quality Control Support

Job Title: Quality Control Support

Employment Status: Full-Time

Classification: Non-Exempt

Work Schedule: 11:00am – 8:00pm Monday-Thursday, 10:00am – 2:00pm Friday or 12:00pm to 9:00pm Monday to Thursday or 10:00 am – 7:00 pm Monday to Thursday.  Must be able to work Day/Swing hours as needed.

Reports to: Quality Control Manager

Supervisory Responsibilities: No

Pay: $19-$23/hour

 

Position Summary: The Quality Control Support representative oversees the Document Control Program and performs testing in the Quality Control Laboratory at least one day weekly, additional laboratory testing may be required as needed.  Responsible for accurately reviewing and processing documentation along with testing and approving incoming raw materials and manufactured products.  Compiles and evaluates statistical data to determine and maintain quality.  The Quality Control Support representative ensures quality through testing and inspecting various stages of the production process.

 

Essential Functions:

  • Scans, organizes, and files all physical copies of ISO documentation produced at the plant. Verifies and destroys all physical documentation following reaching physical retention period.
  • Processes and tracks Document Change Orders and associated training records.
  • Reviews and approves documentation, reviews Quality Control (QC) work orders including review and approval of laboratory data. Responsible for certificate of analysis creation and documentation review.  Performs general documentation review for accuracy of plant documents.
  • Responsible for QC relief testing, which includes the following:

– Performing quality control tests on raw materials and manufactured products in a timely and accurate manner per established guidelines and frequencies.

– Conducting First Piece Inspection quality control tests and inspections on device production.

– Collecting samples including raw materials, validation, in-process, and finished product samples for analytical testing.

– Ensuring the QC support of Environmental Monitoring in Manufacturing along with verification and validation of cleaning processes.

– Calibrating, cleaning, and maintaining laboratory equipment and instruments.

  • Performs in-process audits throughout the course of the shift to verify compliance to both internal procedures and customer specifications.
  • Follows established health and safety procedures and policies.

 

Other Duties

  • Assists in Out of Specification investigations, root cause analysis, and corrective action development.
  • Assists and coordinates samples sent to external laboratory for testing.
  • Supports other departments as needed.
  • Performs other Quality 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 diploma or equivalent is required, Associate degree preferred.
  • Experience performing Kinetic Turbidimetric Endotoxin Testing preferred.
  • One year of Quality Control Laboratory testing experience required.

 

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

  • 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 laboratory equipment operation, troubleshooting, and maintenance.
  • Knowledge of effective and safe laboratory and experimental procedures.
  • Excellent verbal and written communication skills.
  • Strong analytical ability to handle data and results.
  • Excellent time management skills with a proven ability to meet deadlines.
  • Excellent organizational skills and attention to detail.
  • Ability to self-motivate and work without direct supervision.
  • Ability to multi-task and work in an organized manner.
  • Ability to perform laboratory tasks such as pipetting and measuring using a caliper.
  • 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 walk on normal surfaces, stand, and sit; use hands for writing and keyboarding.  The employee is occasionally required to lift, carry, and/or push up to 5-10 lbs., stand, stoop, and bend, walk on uneven surfaces, and reach/stretch.  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.

 

Working Conditions

This position typically functions in office, lab, and warehouse/production areas.  There will be exposure to moderate noise levels, fumes, dust, chemicals, heat/cold, and allergens especially in the warehouse, lab, and production 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.

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