Quality Control Laboratory Specialist

Job Title – Quality Control Laboratory Specialist

Location – Coppell TX 75019

Duration – 06 months contract (covering mat leave)

Shift - M-F 6AM - 3

Position Overview:

As a member of the Quality Control (QC) team contribute through the completion of all assigned and routine laboratory related tasks in compliance with AZ, GMP & SHE standards

Key Accountabilities:

• Ethical conduct and compliance
• Adherence to GLP and GDP
• Provides support services for analysts and chemists in the quality control laboratory including cleaning and maintaining the general laboratory facilities and glassware through 5S
• Responsible for ordering laboratory chemicals and supplies, and inventory management
• Responsible for preparing and shipping testing samples to contract lab
• Responsible for cleaning, organizing, and maintaining lab glassware
• Performs sampling of purified water, compressed air, and environmental monitoring for testing
• Accurately completes all data entry requirements for methods or tasks performed
• Performs actives supporting sample receipt, retain storage, and dispositioning of samples
• Executes analytical methods and/or SOPs, with appropriate documentation
• Reviews data for completeness and accuracy using the applicable method/SOP's
• Execute test plan to support laboratory investigation if needed
• Work with document control department for issuing/archiving logbooks and sample folders if needed
• Work with warehouse team for events occurring during sample receipt
• Perform daily check of lab equipment to assist chemists for testing
• Participate in problem solving activities, including ownership of action items identified through the problem-solving activities
• May fulfill other jobs/responsibilities as directed by management consistent with skill level and training

Qualifications and Experience:

• Bachelor's or associate Degree (preferred but not required), preferably in the chemical or biological sciences with previous experience in a pharmaceutical laboratory.
• Must be able to perform activities to support QC sampling activities including climbing ladders and working in areas with limited access and on catwalks around production equipment.
• Must be day/time, weekend and holiday flexible to support QC sampling activities/testing (routine, validation studies, PW sanitization, etc.).
• Must be able to retrieve, dispense, and dispose of chemicals and reagents according to according to approved procedures.
• Must be adequately trained in Good Laboratory Practice (GLP and GMP) standards and be able to complete all forms legibly and accurately and/or notebooks.
• Must be able to attain proficiency in using AstraZeneca analytical applications required for the completion of assigned tasks.
• Must be able to work at a lab bench or hood and perform the necessary procedures required for sample preparations and clean-up using the current prescribed or validated methodologies
• Excellent verbal communication skills
• Teamwork
• Professionalism
• English Language Skills
• 24/7 facility - some flexibility required due to this. Sometimes staying late. Weekend work is possible but is not predicted to happen often.

DRESS CODE

• Business casual, Required PPE will be provided

Intake Call Notes:

• Entry level support role.
• An associate or bachelor is preferred, but strong lab experience is more important.
• 0-2 years of experience without degree
• Minimum of 2 years’ experience in a pharma industry lab without a degree

Most important things to be considered:

• 2 years of pharma industry experience in a lab.
• Strong documentation skills.
• Must be methodical and follow task schedule.
• Understand regulatory requirements
• Sampling experience, like water sampling, environmental sampling.

Software experience:

• Lims
• SAP

Company Overview:

• Infojini Consulting is a Staffing and Recruitment company and incorporated in Baltimore, MD.
• Infojini caters various hospitals, health & wellness centers, pharmacy, and medical facilities over fifty states across the United States.