QA Technician in Grapevine, TX at APEX Systems

Date Posted: 2/16/2020

Job Snapshot

Job Description

Job #:  1040302
Apex Systems is currently seeking a QA/QC Technician in the Grapevine, TX area.  Please contact Stephen Frazer or Maddy Bewick at or 704.521.6100
Job summary:
Candidate must be able to perform raw material, in-process, finished goods, and cleaning validation testing per USP and AAMI requirements. Accurate testing on the first attempt under pressure of production details is required. Performs a variety of chemical tests and is knowledgeable with instrumental techniques. Responsible for sampling, monitoring, and testing process water quality, as well as check other analyst’s documentation.  Relies on work instructions and pre-established guideline to perform the functions of the job.  Work responsibilities must be performed in accordance with regulatory and industrial standards, and in a timely manner with a high regard for safety and quality. Employee must demonstrate understanding of cGMP, cGLP, USP, and AAMI/ANSI requirements for medical device product manufacture and testing.  Works under the immediate supervision of the Quality Control Supervisor.
Responsibilities include, but are not limited to:
  • Operate the ICP-OES, Flame AA, Polarimeter, Acid titrator, LAL and other analytical instruments.
  • Prepare and qualify test standard solutions.
  • Scheduled daily tasks to be performed in an efficient manner.
  • Produce analytical work in accordance with all applicable SOPs and approved analytical methods.
  • Accurately records raw data in logs and worksheets. Interprets and documents all test results, calculations and completes report summaries.
  • Judges the accuracy of test results. Recognizes OOS/OOT or suspect results and promptly reports them to QC Supervisor.
  • Assists and works with the QC Supervisor in completing laboratory investigations.
  • Perform routine lab equipment calibration and maintenance activities.

Minimum requirements:
  • BS in Science or related degree with at least 1 year of laboratory experience. Experience in the pharmaceutical with FDA guidelines preferred.
  • Must demonstrate appropriate written and verbal communication skills.
  • Must demonstrate competency in the operation, maintenance, performance qualification, and troubleshooting of laboratory equipment.
  • Must be able to follow written instructions in English with attention to detail.
  • Willing to work shifts, including weekends/overtime as required
  • Must be able to pass background/drug check

Expectations/Other skills for this position:
  • Good work history, positive attitude, good attendance record and proven work ethic
  • Safe and efficient equipment operation
  • Strictly comply with Standard Operating Procedures and GMP practices and guidelines
  • Communicate with supervisor and other employees about potential problems or improvements
  • Work well in a team environment, coach/motivate other employees
  • Commitment to continuous improvement
  • Support company culture of quality, accountability, efficiency and teamwork

Bonus Skills
  • Previous experience in a manufacturing environment
  • Knowledge of FDA regulations for medical device/pharmaceutical
  • ASQ or other laboratory certification preferred

EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.