732-661-0400

QA Technician

  • Location: Aurora, OH
  • Type: Contract To Hire
  • Job #36270

QA Technician

$24/hour – Monday to Friday 7a-3:30p – Contract to Hire

This global leader in biopharma manufacturing is seeking an experienced quality professional to join their expanding team.  This is a great opportunity to work at a cutting-edge facility with state-of-the-art equipment and systems.  The successful candidate will have industry experience working in a regulated environment and following GMPs and GDPs. This role is perfect for those who crave upward mobility and career development as this department is experiencing quick growth!

Responsibilities:

  • Inspects shipments, reconciles labels, reviews and releases finished product and other paperwork.
  • Reviews QC testing documentation and results for conformance.
  • Confirms expiration dating and issues Certificates of Analysis for each lot.
  • Reviews and approves/rejects other various quality-related documents.
  • Assists in planning, developing, and implementing quality assurance programs.
  • Responds to customer requests, including but not limited to investigating complaints and completing required paperwork for corrective and preventive actions and associated follow-up.
  • Assists in changing and maintaining ISO and cGMP paperwork. Trains or oversees training.
  • Ensures the quality requirements of all departments are followed and are accurately documented.
  • Completes PM/Calibration documentation files and manages Out of Service Equipment
  • Oversee to assure Validations are performed according to approved protocols and samples provided as requested.
  • Interprets, understands, and manages a variety of technical information.
  • Prepares routine, technical, and special presentations/reports to staff and management as required.
  • Prepares and compiles statistical analysis of quality assurance data.
  • Oversees the writing and maintenance of owner’s process manuals.
  • Coordinate and perform quality assurance system internal audits, investigate non-conformances and determine root cause analyses.
  • Reviews the current policies determining and documenting any areas that may need quality improvements.
  • Perform other duties as assigned.

Qualifications:

  • Bachelor of Science in Microbiology, Chemistry, Biology, or related field
  • 1-3 years of GMP and GDP experience in a regulated environment such as PNG, J&J, Dial, Unilever, etc. (required)
  • SAP experience highly preferred!
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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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