Grade 2 - PST meets minimum requirements and experience for client office and roving (with limited locations) positions, and patient service centers offering minimal services.
Skill and comprehension level required for this category: Phlebotomy certification (where required) from an accredited agency, and a minimum of one year verifiable phlebotomy experience. Exhibit proficiency in blood collection by venipuncture and capillary technique from patients of all age groups, and urine drug screen collections. Able to grasp a firm understanding of the importance of compliance and safety as outlined during new hire orientation and annual training.
Skill Requirements
Administrative: Answer telephones, maintain logs/records, organizational skills, proficiency with numbers, research information, time management, use computerized databases, written and verbal communications.
Machine: Personal computer.
Physical Demands: Speech clarity, utilization of fingers and hands, standing-remaining on one’s feet in an upright position, sitting-remaining in the normal seated position, handling-seizing, holding, grasping.  Moderate physical effort (up to 30 pounds); must comply with applicable safety procedures.
Working Conditions: Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures.
Vision Requirements: Far acuity-ability to see clearly at 20 feet or more; near acuity-ability to see clearly at 20 inches or less; depth perception-ability to judge distance and space relationships; color vision-ability to distinguish and identify different colors.
License/Certification/Education: Requires a High School Diploma or equivalent with a minimum of one year of verifiable phlebotomy experience.  Normally requires a Valid Driver’s License along with a clean driving record.

CAPA: Responsible for identification, investigation and documentation of GPV exceptions. Work with business areas to analyze impact and ensure that appropriate actions are taken to correct and prevent reoccurrence of an issue. DOCUMENTATION & CHANGE CONTROL: Responsible for managing change control process for the GPV Quality Systems documents. Facilitate GPV review and provide feedback for division and corporate policies and procedures. METRICS: Responsible for collection and analysis of key QS data. Issue monthly metrics reports for management review. TRAINING: Provide support to GMS departments on approval and documentation of training using ISOtrain. REGULATORY: Provides support for division, corporate and regulatory audits/ inspections of the Pharmacovigilance systems. CONTINUOUS IMPROVEMENT INITIATIVES: Participate on GPV and GMS cross-functional teams in support of business process improvements. Skills/ Experience 3-5 years experience in Quality Systems support role, including CAPA and Document Change Control activities. Candidate must -have understanding of a Quality System and its function in an organization -have experience utilizing a variety of quality management tools -be able to make sound judgements based on facts and data -work independently and with teams -manage multiple tasks and responsibilities Knowledge of ICH/FDA/ EMA regulations and guidelines for Pharmacovigilance is desirable.