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Product Release Administrator

Scantibodies Laboratory Santee, CA
  • $0.00 Hourly
  • Full Time
  • Employer Unlikely to Respond

Summary:

This position is primarily responsible for review of device history records and coordination of standardized training programs for compliance to regulatory requirements and specifications in order to promote the objectives of the quality system.

Position Objectives:

Candidates must understand the processes related to Quality Assurance Release. Candidates must also have expert knowledge of safety regulations and requirements. Candidates must understand QSRs (GMPs) ISO 9001 Standards (including ISO 13485) and other applicable domestic and international regulations and standards, convey an understanding of the Scantibodies Quality System and communicate and train others on its requirements, and serve as a model for compliance in all aspects of the job.

Essential Duties:

QA Product Release Coordination

  1. Responsible for the timely review and approval for product release and further manufacturing for all departments.                                                                                                       
    1. Checking compliance with GMP (QSR), SLI, and customer specification requirements.
  2. Prepare data sheets                                                                                            
  3. Participate and assist in Regulatory, Internal, and Customer Audits.                        
  4. Prepare and provide reports on status of QA Product Release System.                    
  5. Determine ways to track and improve the QA Product Release System for greater efficiency and improved accuracy.                                                                                       
  6. Trains other department QA Product Release staff.                                                

Training Coordination

  1. Safety Committee Member:                                                                               
    1. Coordinate and conduct company-wide Safety Training
    2. Member of the first response team for chemical spills
    3. Respond to employee accidents and any follow-up needed
    4. Chair bi-monthly safety meetings and keep records of these minutes, memos, and accident reports at SLI
    5. Act as a liaison between management representative and Safety Committee
  2. Coordinate and conduct company-wide ISO and Quality Management System           

Training

  1. Coordinate and perform as instructor for departmental MSDS training                                
  2. Coordinate and provide status reports for Medicare, HIPAA, and other computer based

training applications                                                                                              

  1. Research and recommend purchase of training supplies and/or software                    
  2. Develop additional Training Programs as required                                         
  3. Prepares annual reports of training program status and plans annual                          

company-wide training based on employee needs assessments

  1. Participate and assist in Safety Audits                                                                    

Equipment Used:

Personal Computer

General Office Equipment

Job Specifications:

Associates degree or equivalent work experience required.

Candidates must have minimum of two (2) years experience in a medical device or pharmaceutical environment with at least two (2) years in the quality field and a minimum of two (2) years of Quality Assurance Release.

Candidates must be familiar with QSR (cGMP) and ISO 9001(including ISO 13485) standards.

Candidates must possess “expert” knowledge in the use of computer applications such as MS Word, Excel, and Access and be proficient in drawing and flow chart creation software.

Candidates must have excellent communication skills and be able to effectively interact with staff at all levels.

Candidates must have current safety related certifications and maintain certification.

Working Conditions/Physical & Mental Demands:

Good health and vision corrected as necessary and appropriate.

Supervision of Others:

None

Monetary Responsibilities:

None

EEO:

SLI is an equal opportunity employer and all employees are responsible for maintaining a discrimination and harassment free environment.

Ethics:

All employees are accountable for conducting their daily business responsibilities in an ethical and moral manner.

The above declarations are not intended to be an “all-inclusive” list of duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job.  Rather, they are intended only to describe the general nature of the job.

Approval Signatures:

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