Quality Control Laboratory Specialist

BR 47.57
Location: Coppell TX
Shift: M-F 6AM - 3
FULLY ONSITE
Length of assignment: end of Octoberr - covering project

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

SHIFT
Monday through Friday, 6 am to 3 pm
Potential weekend work required according to business
DRESS CODE
Business casual, Required PPE will be provided

COVID VACCINATION REQUIRED per company policy

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
Team size: 25 including manager
24/7 facility - some flexibility required due to this. Sometimes staying late. Weekend work is possible but is not predicted to happen often.
Interview process: One (1) 60 min onsite interview with three supervisors/managers