Laboratory Assistant 2 (HAI Lead) (R1080205) in San Juan Capistrano, CA at IQVIA™

Date Posted: 7/15/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    7/15/2019
  • Job ID:
    R1080205

Job Description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

SUMMARY

The Lead Technician is responsible for leading and overseeing the execution of Vaccines operational responsibilities and testing within a given assay, completing all required documentation relevant to testing and release of data within that assay.  Supports applicable regulations including ISO, Local, State, and/or Federal requirements.

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Ensures compliance with established TSOPs and reporting schedules for assigned assay. Ensures the work is done within contracted timeline.
  • Demonstrate leadership through accountability and collaboration in daily activities.
  • Consistently demonstrate a high level of initiative and problem-solving ability.
  • Coordinate efforts to effectively work with others in a way that is productive and promotes cooperation. Recognized as an organized participant or leader of meetings.
  • Demonstrate effective two-way communication with co-workers, immediate managers, suppliers, internal and external customers, via meetings, written and verbal interactions, to create an informed positive environment.
  • Demonstrate competency in two or more of the following responsibilities:

Research and Development:

Assist with validation experiments for new assays or to modify existing assays.

Reagent manufacturing:

Maintain up to date batch records and SOPs and prepare SOPs. Coordinate production activities to achieve effective and efficient use of facilities and personnel to meet production schedules and budgets.

Establish efficient policies and leads continuous improvement efforts to reduce costs and increase production efficiencies.

Follow standard operating procedures and specifications within the Quality Systems.

Work with Operations and Scientific staff to develop strategies and policies to facilitate the transfer of new assays and technologies into production assays.

Instrument specialist:

Perform complex preventive maintenance-including periodic optimization of instrumentation.

Perform experiments to evaluate new laboratory instruments.

Assists with troubleshooting and acts as service representative liaison.

Responsible for instrument documentation and upkeep of records.

Ensure appropriate documentation is in place to comply with guidelines of inspection agencies, manufacturers, clients or department recommendations.

Responsible for instrument computer maintenance to include cleaning of extraneous files, software back up, checking programming changes, and archiving of data.

Maintain a high level of competency and expertise in the area of instrumentation i.e.: reading related articles, attending workshops or in-house lectures.

Maintain instrument inventory of critical parts for instrumentation.

Operational support:

Assist in scheduling, monitoring and adjusting workflow to meet established department goals and ensure compliance to regulatory requirements.

Help coordinate schedules for the transfer of new assays and procedures to Operations. Ensure all documentation is complete and on file.

Ensure related SOPs are up to date and able to prepare technical, general, or procedural SOP's.

Support, implement and ensure compliance of assigned assay area and company policies (i.e. Health and Safety, HR, QA, Six, Sigma, etc.). Manage training records for trainees.

Regularly update the departmental standard operating procedures and database to accurately reflect the current process.

Serve as a Senior Laboratory Associate capacity as needed.

SUPERVISORY RESPONSIBILITIES

Leads employees in the performance of a given assay. Carries out responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; appraising performance; competency testing, addressing complaints and resolving problems, attend management meetings and additional meetings when required, and participates in Goal planning and project management of the department.

EDUCATION and/or EXPERIENCE

  • Bachelor of Science or Bachelor of Arts and 2–4 years of previous laboratory experience.
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within defined practices and policies in selected methods and techniques for obtaining solutions. Generally, receives no instructions on routine work, and exhibits general ability to work independently with minimal supervision.
  • Computer skills: word processing skills using Windows based software (Word, Excel, etc.). Other automation skills helpful. Typing skills desirable.

LANGUAGE SKILLS

  • Demonstrate effective two-way communication with co-workers, immediate managers, suppliers, internal and external customers, via meetings, written and verbal interactions, to create an informed positive environment.

MATHEMATICAL SKILLS

  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals.

REASONING ABILITY

  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to understand a variety of instructions furnished in written, oral, diagram or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

None.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel.  The employee frequently is required to sit.  The employee is occasionally required to stand, walk, reach with hands and arms, and talk or hear.  The employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment is usually moderate.

OSHA RISK CATEGORY

Category I – Tasks which involve exposure to blood, bodily fluids, tissues, hepatitis viruses, or human immunodeficiency viruses.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1080205