Manager, Immunoassay Sample Analysis Laboratory - Marietta, GA - (R1026456) in Marietta, GA at IQVIA™

Date Posted: 6/16/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Marietta, GA
  • Experience:
    Not Specified
  • Date Posted:
    6/16/2018
  • Job ID:
    R1026456

Job Description

Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.

Description

 
We are looking for candidates with scientific experience in Immunoanalytical assay development, validation, and/or analysis. Are you interested in taking your direct supervisory skills to the next level?  

 
PURPOSE
Responsible for the operation and regulatory compliance of the Immunoassay Sample Analysis Laboratories while managing the team of laboratory analysts.

RESPONSIBILITIES
  • Manage and direct the daily activities of assigned laboratory work group(s) through appropriate delegation, technical skills training, and work supervision.
  • Meet regularly with staff and senior management to discuss and resolve workload and technical issues.
  • Screen and assign workload; Plan, prioritize and assign tasks and projects.
  • Counsel, train and coach laboratory staff. 
  • Assist in developing performance standards - Monitor work, develop staff skills and evaluate performance.
  • Assist in establishment and revision of laboratory policies and procedures.
  • Maintain appropriate control and quality assurance procedures. Ensure compliance with safety requirements.
  • Keep abreast of new technical developments.
  • Assist with implementation of new tests, equipment, programs and/or procedures in the assigned area(s) as needed.
  • Contribute to continuous improvement initiatives to increase quality of services and operational efficiency.
  • Foster a unified culture and facilitate collaboration, cooperation, sharing of information and teamwork.
  • Participate in initiatives to improve employee engagement to positively impact operational results, customer satisfaction and employee retention.
  • Manage staff in accordance with organization’s policies and applicable regulations.
  • Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
  • Ensures laboratory equipment is operational and maintained to optimum operating conditions at all times.
  • Maintain the scientific integrity of the data produced by the sample analysis laboratory.
  • Perform scientific review of bioanalytical repots and assist with failed run analysis.
  • Maintain effective communications between the sample analysis lab and other departments.
  • Communicate department issues and provide status updates to management team.
  • Track department productivity and quality.
  • Manage purchasing and approval of laboratory supplies.
  • Responsible for tracking all lab inventory used in experiments.

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Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • In depth knowledge of clinical testing procedures and applicable laboratory testing regulations.
  • Knowledgeable and proficient in I/A PK, ADA, and NAb analysis.
  • Ability to perform accurate and precise processing of client samples.
  • Working knowledge of quality assurance and quality control principles and in depth knowledge of company-specific program requirements.
  • Knowledge of occupational safety and health rules and regulations.
  • Good written and oral communication skills.
  • Effective supervision and coaching skills.
  • High ethical standards.
  • Ability to assess and prioritize multiple tasks, projects and demands.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Ability to adhere to iQVIA, Q2 Solutions, and client Standard Operating Procedures
  • Ability to complete documentation per iQVIA, Q2 Solutions, and GLP requirements, as applicable.
  • Ability to critically assess data and has a sharp attention to detail.
  • Knowledgeable and experienced in Immunoassay / Immunogenicity including laboratory operations and project management.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor's degree in a  sciences related field and 7 years relevant experience ;or equivalent combination of education, training and experience.
  • Minimum of 5 years managing staff (preferred 7 or more direct reports).
  • Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.

PHYSICAL REQUIREMENTS
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
  • Work is performed in a laboratory environment, full manual dexterity and visual acuity required
  • May be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools and equipment
  • Occasional travel

EEO Minorities/Females/Protected Veterans/Disabled
 

 

 

Job ID: R1026456