Skip to main content
Search

Search FMCNA Jobs

Quality Systems Technician I

Oregon, OH
Apply Now
Job ID 19000BC2

Available Openings 1

Position Specific InformationThird Shift

PURPOSE AND SCOPE:

Conducts Quality audits of products assuring company standards are maintained and product integrity is preserved. Consults with management to resolve quality, production, and efficiency problems. Functions as an information source to employees when quality issues occur.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Under close supervision, acquires job skills and learns company policies and procedures to complete routine tasks. Fulfill duties in accordance with requirements of the QSR regulations, the ISO-9001 standard, Corporate and on-site policies and procedures.

  • Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.

  • Develop plans by conducting analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.

  • Works on assignments that are routine in nature; determines whether or not communications regarding company equipment are complaints and whether or not complaints might be reportable to the FDA.

  • Analyzes equipment complaints to determine the probability that the reported problem is resolved and, if not, whether additional action to resolve the problem needs to be taken.

  • Assures laboratory equipment and instrumentation is calibrated and properly maintained

  • Performs operation, including routine maintenance/cleaning for analytical instruments to ensure proper operation.

  • Documents investigation steps and results.

  • Communicates with company personnel to investigate complaints.

  • Follows all policies, guidelines, and Standard Operating Procedures (SOPs) as required.

  • May refer to senior staff for assistance with day-to-day problems that may arise.

  • Escalates issues to supervisor for resolution, as deemed necessary.

  • Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.

  • Assists with various projects as assigned by direct supervisor.

  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.


PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Involves moderately active work involving walking and/or standing for considerable lengths of time.  Bending to floor level is required and the employee must be able to routinely lift objects weighing up to 50 lbs as high as 5 ft above floor level. 

EDUCATION:

  • High School Diploma required.

  • Associate’s Degree or Bachelor’s Degree in Science preferred (Chemistry or Microbiology preferred).

EXPERIENCE AND REQUIRED SKILLS:

  • Minimum 0 – 1 years of related experience.

  • Understands basic concepts and principles of dialysis.

  • Mathematical aptitude required with a good background in algebraic skills and measurement skills.

  • Basic computer skills with database, spreadsheet, and word-processing programs.

  • Strong oral and written communication skills.

  • Strong attention to detail.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

ADDENDUM:

Concentrates

  • Performs tasks which include but are not limited to: sampling, inspecting, and testing packaging and chemical components according to established procedures and laboratory methodology to ensure conformance with approved specifications.

  • Performs quality testing of materials, in-process products, and finished products.

  • Samples and tests in process and finished product according to established procedures and laboratory methodology to ensure conformance with approved specifications.

  • Records all inspection and testing data on appropriate report sheet/log book per approved procedure and/or good laboratory practices. Enters Data in spreadsheets for the purpose of tracking and trending.

  • Provides support to QS Inspectors for receipt of raw materials and packaging components, as well as for the printing and issuing of final product labels to Production personnel.

    Experience and Required Skills

  • Understands fundamental concepts of working in analytical chemistry or microbiology lab as an analyst.

  • General knowledge of GMP regulations, Good Laboratory Practices, or comparable Quality or laboratory standards.

  • Knowledge of commonly used analytical chemistry and/or microbiological laboratory methods.

Reynosa, Mexico

  • Verifies condition of lots that arrive from sterilizer to PSR; reports damaged boxes to sterilizer; requests the damage report and communicates it to Reynosa Release Coordinators.

  • Verifies lots and quantities arriving from sterilizer to PSR; matches the accounting report sent by Release Coordinator, reporting any differences to Reynosa and the sterilizer.

  • Controls quarantine and on-hold areas so there are no mixtures; ensures areas are fenced and identified.

  • Ensures quarantine or on-hold product is identified with validation labels, NCR, DN, or other applicable label in accordance with product status.

  • Removes quarantine/on-hold identification labels when product release is communicated by Release Coordinator.

  • Ensures that only product and quantities indicated as released are shipped to the distribution center, in accordance with accounting report sent by Release Coordinator. Maintains appropriate segregation between released and quarantine product.

  • Visits sterilizers when required due to quality problems.

  • Coordinates with PSR Warehouse Supervisor to perform sampling of lots in collaboration with warehouse personnel, when required due to quality problems.

  • Samples lots for laboratory tests (i.e. EO, residuals, etc.) as required by laboratory or Release Coordinator. Scraps remaining units of the boxes.

  • Ensures PSR area is maintained in accordance with cleanliness, pest control, and environmental requirements.

  • Verifies shipment of lots returning to Reynosa (TBR – To be returned) is correct in both lots and quantities. Ensures accounting form and transfer receipt are present to approve the shipment.

  • Reports irregularities that may impact product or other quality system to DHR coordinators and supervisor.

  • Maintains continuous communication with the Release Coordinator to ensure proper product controls.

  • Ensures a good working environment with warehouse personnel to ensure product and quality system control.

  • Works with Pharr Warehouse Supervisor for the matters of sample shipment, pallet requisition, etc.

  • Communicates with Reynosa personnel to make material or equipment purchase requisitions needed to work in PSR.

  • Contacts Reynosa to make purchase orders to buy necessary materials/equipment per PSR quality (i.e. ice, coolers, etc.).

  • Complies with trainings in a timely manner.

  • Keeps report of boxes damaged by cargo, with identified and non-identified boxes of the sterilizer.

  • Keeps daily inventory of product status in PSR.