·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.
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%)