Job Description
PositionOverview
Position Title: Quality SystemsAdministrator
Location: Springfield, Missouri
Last Updated: April 2020
Position Summary
Assist the Quality Manager in maintaining all Quality Systems at the Alltrista,Springfield facility will help to monitor and improve quality recordkeeping,batch record systems, ISO documents, and internal/external audits.
Primary Functions
Oversees and administers the Alltrista Springfield Quality systems including all internal and external audits.
· Maintains internal and external customers currentspecification revision and communicates to other plant personnel.
· Maintains internal and external document controllogs.
· Approves each batch record in a timely manner toensure all components are complete and accurate.
· Recommends changes and implements changes to batchrecord review.
· Identify any necessary deviations for correctiveaction.
· Ensures that project books and protocols arecomplete, accurate, and controlled in a central location by quality assurance.
· Maintains records and files for GoodManufacturing Practices.
· Writes, reviews, and implements new documentsunder the direction of the Quality Manager.
· Performs revision changes to current documents anddisposes of expired documents.
· Works closely with other departments to facilitatethe total quality function by completing, assisting in directing, andparticipating in internal audits.
· Identifies any deviations for corrective actionand follows up for closure.
· Assists in the necessary activities relative tointernal and external customer complaints, audit and disposition of goods,corrective action, and documentation.
· Assists in training all new and existing qualitypersonnel on new and revised documents.
· Assists with training all new and existing plantpersonnel on current Good Manufacturing Practices.
· Assists in developing and maintaining labelcontrol procedures and identifies deviations for corrective actions and followup.
· Reviews new and revised customer specificationsand product drawings for identifying any necessary additions or alterations toexisting tooling, techniques, procedures, or other normal operating procedures.
· Assures all non-conforming materials are properlydispositioned and that the necessary corrective actions are effective andimplemented in a timely manner.
Key Qualifications
· Certified Quality Auditor and Lead Auditorcertification preferred.
· Minimum two to five years of experience in adocument control position with demonstrated successful performance.
· Minimum two to five years metrology/precisionmeasurement experience.
· Minimum two years of experience in an injectionmolding and quality assurance environment.
· Working knowledge of SPC/SQC, statisticalsampling, and auditing principles.
· Familiarity with 21 CFR 820 medical deviceregulations, Good Manufacturing Practices, ISO 9001 or similar Quality Systems.
· Familiarity with reviewing and executingvalidation protocols and validations or use of electronic document controlsystems.
· Working knowledge of computer applications.
Physical Requirements
The conditions herein are representative of those that mustbe met by an employee to successfully perform the essential functions of thisjob. Reasonable accommodations may be made to enable individuals withdisabilities to perform essential job functions. Please refer to thePhysical Job Description, which is contained as a separate document, for moredetail.
Environment: Normal manufacturingenvironments; work with machinery and media in or around confined spaces;exposure to chemicals, grease and oils.
Physical: Sufficient physical ability toperform heavy lifting and carrying; reaching, kneeling, crawling, climbing;standing for moderate periods of time.
Vision: See in the normal visual range withor without correction; vision sufficient to read computer screens and printeddocuments.
Hearing: Hear in the normal audio range withor without correction.
Other: Ability to work overtime oroccasionally on weekends with short notice.
The above statementsdescribe the general nature and level of responsibilities for this position,and are not to be construed as an exhaustive list of all responsibilities,duties, and skills required of this position. Company management may assignother relevant, business-related duties.