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Department: Quality Assurance Operation - 017
Schedule: Full Time
Shift: Days
Hours: 8-5pm
Salary Range: Grade 11/12/13: $15.08-$24.36
Job Details:
  • High School/GED
  • POSITION SUMMARY:


    ·          Provides quality support for Quality Engineering functions and leads activities as assigned.

    ·          Performs investigations for product nonconformance/process noncompliance issues and documents exceptions appropriately in the CAPA System.

    ·          Performs CAPA investigations as assigned.

    ·          Participates and / or leads review and disposition of non-conforming product (PQRB / returns / complaints).

    ·          Authors and executes validation protocols and documents the results in a validation report.

    ·          Performs audits of products and processes and documents the results appropriately.

    ·          Assists in maintaining relevant WI’s, SOP’s and other documentation.

    ·          Performs product acceptance testing, quality inspections, data entry and data corrections.

    ·          Performs investigation and corrections on manufacturing records.

    ·          Assists in performing, documenting and training personnel to environmental monitoring, environmental control and facility/equipment cleaning activities.

    ·          Assists in performing, documenting and training personnel to comply with aseptic techniques and practices.

    ·          Provides support as necessary for environmental monitoring investigations.

    ·          May perform small animal (primarily rat) surgeries in support of the ectopic rat QC screening program.  Duties include osteoinductivity (OI) / chondroinductivity (CI) implant / explant testing, OI /CI slide evaluation, scoring, documentation and process ownership.

     


    EDUCATION/EXPERIENCE REQUIRED AND/OR PREFERRED: (list required and preferred separately)

    Quality Technician I (Grade 11): 

    ·          High School diploma and at least one year experience in tissue bank, medical device or Quality Control environment.  

    Quality Technician II (Grade 12): 

    ·          AA required or High School diploma plus at least three years’ experience in tissue bank, medical device or Quality Control environment.

    ·          Bachelor’s degree preferred (nonspecific discipline).

    ·          ASQ Certification(s) desired.

    Quality Technician Specialist (Grade 13): 

    ·          AA required or High School diploma plus at least five years’ experience in tissue bank, medical device or Quality Control environment.

    ·          Bachelor’s degree preferred (nonspecific discipline).

    ·          ASQ Certification(s) desired.

     

    KNOWLEDGE, SKILLS AND ABILITIES: (list required and preferred separately)

    ·          Ability to take initiative and work independently

    ·          Basic computer software skills, including but not limited to:  MS Office, Excel, and Access

    ·          Knowledge (or ability to learn) relevant T-track functions

    ·          Ability to utilize measurement and inspection tools (e.g. calipers, gages, microscope)

    ·          Ability to record and review information accurately

    ·          Effective written and oral communication skills

    ·          Willingness to handle and process human and animal tissue

     

    REQUIREMENTS FOR SMALL ANIMAL SURGERY SUPPORT (if required)

    ·          Must have ability to perform basic surgeries & scoring, maintain rat supply & schedule surgeries. Must obtain approval from The Institutional Animal Care and Use Committee (IACUC) in order to perform small animal surgeries within one year of obtaining position.

    ·          Ability to work with anesthetic gasses on a frequent basis.

    This position may require the use of personal protective equipment during various tasks/activities including but not limited to, gloves, masks & glasses.

    List activity requirements and percentage of time:  KEY:  Not at all (0%), Occasional (1-33%),  Frequent (34-66%), Constant (67-100%)

     

    Climbing:   Not at all (0%)                       Bending: Frequent (34-66%)                             Kneeling/Crawling with force:   Not at all (0%)                     

    Pulling: Occasional (1-33%)                  Reaching Above Head: Occasional (1-33%)    Twisting at waist: Occasional (1-33%)

    Lift above shoulders: Not at all (0%)                                                                                   Lift from floor level: Occasional (1-33%)           

     

    Physical Requirements:

    Medium work:  Physically handle objects up to 50 lbs. frequently.

    Stand for 6 hours/day           Sit for 8 hours/day                 Perform repetitive tasks/motions    Have good manual dexterity          

    Have good eye/hand/foot coordination                        Hear alarms/telephone/normal voice             Have Clarity of Vision                     

    Near Acuity (Clarity of vision at 20 inches or less)      Far Acuity (Clarity of vision at 20 feet or more)             Distinguish colors

     WORKING CONDITIONS: Biomedical manufacturing environment.  Potential hazards include exposure to:

    Hazardous chemicals: Occasional (1-33%)                                       Blood or body fluids: Frequent (34-66%)

    Extreme conditions, hot or cold: Occasional (1-33%)                      Communicable diseases: Occasional (1-33%)

    Saw Blades, needles or other sharp objects: Frequent (34-66%)   Unprotected heights: Not at all (0%)

    Moving mechanical parts: Occasional (1-33%)                                 Latex exposure: Frequent (34-66%)   

For HR Use Only:

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Tissue Definitions

Allograft Tissue
Tissue (bone, tendons, ligaments, skin, heart valves) taken from one person for transplantation into another.
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Xenograft Tissue
Animal-derived tissue (bovine or porcine) that is transplanted to a human recipient.
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