Quality Technician
RTI Biologics - Alachua, FL

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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%)

RTI Surgical - 20 months ago - save job - block
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About this company
10 reviews
RTI Biologics Inc. makes use of natural tissues and technologies to produce orthopedic, cardiovascular and other surgical implants that...