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Department: Donor Services Corporate - 001
Schedule: Full Time
Shift: Days
Hours: 8-5
Salary Range: Grade 14 - $42,947.00 - $56,486.00
Job Details:
  • Associates Degree
  • POSITION SUMMARY:

    ·         Manages chart review process of RTI Donor Services screening, recovery, and operational activities, forms and records to ensure compliance to procedures as well as good documentation practices. 

    ·         Functions as RTIDS liaison with processors to manage donor pending list, ensure information is sent timely and requests are responded to in a timely manner. 

    ·         Manages the RTIDS Risk Analysis Program including Quality Notifications, Change Control, Exceptions and CAPAs.  Manages and retains associated documents/form related to the program to ensure timely completion.  Manages the electronic software systems and databases associated with this function.

    ·         Manages development of RTIDS Standard Operating Procedures (SOPs), Work Instructions Policies and other internal and external communications and publications including technical writing and timely release and promotion.

    ·         Monitors and provides trend analysis of review and audit data to appropriate management.  Coordinates annual review of operational data with management team.   

    ·         Performs focused internal audits of RTIDS functions to ensure compliance with all applicable state, federal and international regulations including AATB standards for which Donor Services activities are performed.

    ·         Participates and assists in internal and external requests including follow up of regulatory, AATB, internal and partner audits as necessary.  Assists in immediate action and correction of operational and customer services issues and complaints. 

    ·         Takes responsibility for professional development, supports a learning environment, and meets professional competency

    requirements to support corporate balanced scorecard goals.

     

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

    ·         AS/AA Degree or equivalent education / experience required

    ·         Minimum two years quality assurance, regulatory affairs or other related experience with a tissue or blood bank, medical device or drug company or in the healthcare industry required

    ·         AATB CTBS certification required

    ·         Knowledge of FDA regulations, ISO and AATB standards preferred 

     

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

    ·         Strong interpersonal, organizational, verbal and written communication skills.

    ·         Advanced skills of  Microsoft Office Suite

    ·         Detail oriented 

    ·         Maintain confidentiality

    ·         Work with minimal supervision

    ·         Minimum travel required

    This position may require the use of personal protective equipment during various tasks/activities including but not limited to, gloves, masks and safety 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: Occasional (1-33%)                         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: Occasional (1-33%)                                                                       Lift from floor level: Occasional (1-33%)         

     

    Physical Requirements:

    Sedetary work: Prolonged periods of sitting & physically handle objects up to 10 lbs occasionally.

    Stand for  3 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: Not at all (0%)                                               Blood or body fluids: Not at all (0%)

    Extreme conditions, hot or cold: Not at all (0%)                              Communicable diseases: Not at all (0%)

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

    Moving mechanical parts: Not at all (0%)                                         Latex exposure: Not at all (0%)         

  • EOE/M/F/Vets/Disabled
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