Quality Control Specialist I

Job Locations US-PA-Bethlehem
ID
2020-1205
Category
Manufacturing Operations
Type
Regular Full-Time

Overview

Quality Control Specialist I personnel perform procedures that include evaluation of raw materials, in-process components, finished products, stability testing, equipment quality control, and equipment maintenance in compliance with guidelines established by Orasure Technologies and regulatory agencies. This position is on a 2nd shift M-F 2:30-11pm with training on 1st shift M-F 6:30am-3pm.

Responsibilities

  • Perform all procedures accurately and according to written Work Instructions and SOPS as indicated in the Quality Control procedures and other applicable facility procedures.
  • Perform testing at all levels of production including raw materials, in-process components, finished products and stability testing.
  • Perform visual finished product inspections.
  • Perform customer complaint investigations including required testing, evaluations and batch history reviews.
  • Perform failure investigations including investigative testing.
  • Recommend acceptance or rejection of raw material, component, finished product and other materials evaluated based upon established specifications.
  • Document all paperwork according to procedures and protocols.
  • Completes appropriate computer entries accurately.
  • Maintains neat and legible manual forms.
  • Maintains a clean, organized work area and keeps supplies stocked at the bench.
  • Assists in writing work instructions.
  • Assist in the training of QC laboratory employees in new methods and procedures.
  • Conduct and report on the product stability testing program designed to support product stability claims; recommend storage and shelf life claims according to data.
  • Develop and maintain systems to track trends in product and component quality.
  • Identify and report on positive and negative product quality trends through trend analysis.
  • Develop improved quality test methods, equipment and standards intended to increase product quality or productivity or reduce operating costs.
  • Actively participates in performing validation protocols.
  • Order inventory and supply items as needed.
  • Notifies Quality Control Director, QC Supervisor or designee of equipment and/or procedural problems.
  • Performs other job duties and special assignments and projects as put forth by the Quality Control Director, QC Supervisor or designee.
  • Documents nonconforming product according to the Corrective and Preventive Action System (CAPA).
  • At the discretion of the Quality Control Director, QC Supervisor or designee, perform failure investigations; identify potential causes of failure, document investigations and evaluations performed.
  • Demonstrates a cooperative attitude when performing duties in conjunction with other departments.
  • Refers all complaints to the Quality Control Director, QC Supervisor or designee.
  • Adheres to written and oral directives.
  • Displays positive working relationships and cooperates with work assignments in the best interest of the department.
  • Provides assistance to coworkers when necessary.

Qualifications

Educational Requirements: 

  • 2 year degree in Chemistry, Biology, Medical Technology, Related Science or equivalent regulated industry work experience

Experience:

  • 1 years previous laboratory experience
  • Computer Literate
  • Pipetting experience
  • GMP and FDA regulated environment 

 Skills:                                                 

  • Dependable Work Habits
  • Detail Oriented
  • Organized
  • Cooperative Attitude

 Special Requirements:

  • Willing to be flexible concerning work schedule.
  • Ability to understand technological and regulatory texts and procedures
  • Ability to interpret, communicate and apply oral and written instructions.
  • Ability to use basic statistics.

 OraSure and its subsidiaries is committed to ensuring equal employment opportunities for all. All employment decisions, policies and practices are in accordance with applicable federal, state and local anti-discrimination laws.

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