Plasma - Quality Assurance Specialist

Plasma - Quality Assurance Specialist page is loaded## Plasma - Quality Assurance Specialist locations:
Anniston, ALtime type:
Full time posted on:
Posted Todayjob requisition :
R8370

Essential

Job Responsibilities and Duties    
• Perform donor record file review  
• Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual  
• Review medical reports and communication  
• Perform reviews of equipment incidents  
• Verification and release of sample shipment  
• Responsible for the inspection and release of incoming supplies  
• Initiate deviation reports as needed  
• Perform Weekly employee observations  
• Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures  
• Reviews the documentation of unsuitable test results and the disposition of the associated units    In the absence of the Manager of Center Quality Assurance:  
• Conduct root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product  
• Review of equipment records and donor system information, if applicable, to approve out of service equipment for use  
• Review and approval of deferred donor reinstatement activities  
• Review lookback information  
• Waste shipment review  
• Initiates investigations and reports any supplies that have not met quality specifications and requirements before use  
• Review medical incident reports and documentation  Qualifications  
• High school diploma, GED or equivalent required.  Associates degree preferred or a minimum of (3) three to (6) six months quality or plasma industry experience required.
Requirements  
• Strong verbal and written communication skills  
• Must have above average problem-solving and decision-making abilities  
• Proficiency with computers  
• Must have explicit attention to detail  
• Must have excellent analytical skills, organization skills, and follow-up  
• Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals  
• Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables    

Physical Requirements  
• Use hands to handle or feel objects, tools, or controls; reach with hands and arms; and talk or hear  
• Frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee  
• Manual dexterity to perform all phases of donor plasmapheresis  
• Ability to make and analyze a physical assessment of heart, lung sounds, signs of drug use, etc.  
• Ability to stand for extended periods of time for up to four (4) hours at a time  
• Ability to lift, tug, pull up to fifty (50) pounds

Today, LFB is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals with plasma-derived or recombinant medicinal products in three major therapeutic areas:  immunology, haemostasis, and intensive care.
Life of patients is our purpose! Let's Work together in a climate of sharing, mutual exchange, trust and transparency.  We are committed to hiring a diverse and talented workforce. AA/M/F/D/V. This organization participates in E-Verify.
#J-18808-Ljbffr