Quality Assurance - Sample Management and Labels

2 Months ago • 2-4 Years • Quality Assurance

Job Summary

Job Description

This Quality Assurance role focuses on sample management and labeling of clinical trial materials at Keywords Studios in Indianapolis, Indiana. Responsibilities include quality verification of documentation related to sample receipt, inspection, and retention; coordinating sample receipt and inspection with other functional areas; data verification and documentation in SAP; annual RIB sample inspection; sample processing for destruction; label review and approval; procedure and tool review with feedback for improvement; and oversight of ICI's, change controls, and deviations. The role involves a mix of desk-based administrative tasks and warehouse-based activities requiring attention to GMPs and GDPs. The ideal candidate will possess a Bachelor's or Associate's degree with relevant experience, warehouse experience, proficiency in Microsoft Office Suite and other software (TW, QDoc, SAP), and the ability to work in a chilled environment (5 deg C).
Must have:
  • Bachelor's/Associate's Degree
  • Warehouse experience
  • Microsoft Office Suite proficiency
  • GMP/GDP compliance knowledge
  • Sample management & labeling
  • SAP experience
Perks:
  • Medical, dental, and vision benefits
  • Paid time off
  • 401(k) with employer matching

Job Details

Pay rate: $25.00+/hr

Work Hours: Monday-Friday, 8am-5pm With the ability to work shifts as needed (morning, afternoon based on future business needs)

Quality Assurance provides quality oversight of the sample management and labeling of clinical trial materials. The role is responsible for ensuring compliance with all applicable GMPs, GDPs, internal standards, procedures for sample management and labels activities PRD. Mix of desk-based administrative tasks and warehouse-based activities.

Key Responsibilities:

  • Provide Quality verification of documentation related to receipt, inspection and retention of samples (Retention sample, Reference sample, Rib samples, etc.).
  • Coordinate samples receive and inspection with other functional area (API, DP, vTeam, etc.)
  • Provide Quality verification of samples data and document in SAP.
  • Support with annual RIB sample inspection
  • Process samples for destruction
  • Review and approval of Labels
  • Review procedures, tools and provide feedback for process improvement
  • Initiation, complete and QA oversight of ICI’s, Change controls and deviations
  • Perform other duties as required.

Keywords provides a competitive compensation package, good benefits and a casual, fun, productive and supportive working environment. We empower people to perform to the best of their ability with our “can do” attitude. We appreciate and embrace flexibility and learn at every opportunity to grow ourselves through experience, training and tackling new challenges. This is what makes us Keywordians

Requirements

  • Bachelors’ Degree/Associate Degree with previous work experience.
  • Basic computer skills including Microsoft Office, TW, QDoc, SAP, and web-based applications
  • Previous warehouse experience
  • Willingness/ability to work in a chilled environment (5 deg C)
  • Standing, lifting (up to 50 lbs.), and bending are required
  • Ability to work off hours and weekends
  • Must be able to pass background check and drug screen.

Benefits

Keywords provides all its contingent workforce with:

  • Medical, dental and vision benefits
  • Paid time off (including sick and select holidays)
  • 401(k) enrollment with 3% employer matching

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

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At Keywords, we deliver clients the benefits of the strengthened Engage service line, combining our Player Support and Marketing offerings.

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