Quality Control Laboratory Specialist

Quality Control Team Member

Location:

Coppell TX

Shift: Monday through Friday, 6 am to 3 pm; potential weekend work required according to business

Length of assignment: end of October; 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 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

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