Acceptability Technician in Centennial, CO at Apex Life Sciences

Date Posted: 5/10/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    5/10/2018
  • Job ID:
    847524

Job Description


We are looking for a mid-level QC/QA candidate to join the team for a Biotech client of ours! If interested in being considered immediately, please email your contact information and resume to dsimpson@apexlifesciences.com

The Acceptability Technician has the responsibility and authority to approve or reject material, as well as discontinue processing and/or release of material. responsibilities include the review of processing records, completion of quality documents, and visual inspections of in process and final labeled material, in accordance with all applicable regulatory standards. Frequent communication with multiple departments is an integral part of the job.

Essential Duties And Responsibilities:
• Participate in material receiving activities, ensuring all required information is present and material requirements are met.
• Evaluate session/batch records for approval and ensure that any corrections are identified and completed prior to acceptance.
• Review session/batch outputs to ensure all products meet the applicable specification and regulatory requirements.
• Ensure physical outputs match electronic outputs and ensure the appropriate QC samples were taken.
• Visually inspect all in process and final labeled product per the applicable specification. Ensure all visually rejected material is dispositioned appropriately through the applicable Quality System.
• Ensure timely and accurate sample processing, which includes sample handling, preparation, documentation, data entry, assignment of test codes, and distribution of all Quality Control Tests intended for various testing laboratories.
• Ensure the proper storage and handling of all Quality Control Tests until sample processing is complete.
• Prepare samples to be shipped to the testing laboratories in accordance with applicable procedures.
• Provide technical support and act as a technical resource for all sample management and sample submission related activities.
• Contact testing laboratories, when necessary, to obtain and clarify missing or unclear information to ensure that identification of test codes and sample contents are accurate.
• Assist Quality Management in collection of data, analysis of data, and report development.
• Responsible for quality review of all final labeling release activities.
• Review final labeled product and ensure that any corrections are identified and completed prior to final release.
• Coordinates decisions for corrections and elevates to Supervisor as necessary.
• Involved in making quality decisions about products based on requirements outlined in SOPs, WIs, and Specs.
• Participate in projects impacting production, inventory or evaluation and maintain consistent cross-functional communication with all departments, shifts and management.

Minimum Requirements

• 2 years Quality Assurance or Quality Control experience working in a regulated industry

• Proficiency in Microsoft Applications, specifically Excel, Word and Outlook

• High School Diploma or equivalent
 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, 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 employeeservices@apexsystemsinc.com or 844-463-6178.