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QC Coordinator/Lab Technician

  • Cleveland, TN, United States

$19 to $20 USD / hour

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Job details

Pay
$19 to $20 USD / hour
Apply by
Experience
Years of experience: 4 years
Posting language
English
Posted

Original job description

Coordinate end-to-end stability studies across the company - from protocol design and sample management to regulatory alignment and data verification. Key Responsibilities Protocol & Documentation: Author, review, and archive batch-specific stability protocols, change controls, and deviations. Sample Management: Calculate required sample quantities, establish storage conditions, coordinate timely sample pulls, and log sampling requirements in batch records. ️ Planning & Tracking: Manage test scheduling, forecasting, and study timelines. Data Governance: Oversee data entry, retrieval, verification, and summary reporting. Compliance & Change Control: Assess product, API, and packaging specification changes to evaluate regulatory impact and update stability protocols accordingly.

salary: $19 - $20 per hour shift: First work hours: 6 AM - 2:30 PM education: High School

Responsibilities

Study Protocol Management

  •  Create, batch specific stability study protocols.
  •  Determine stability sample requirements, develop stability protocols.
  •  Calculate sample quantities required for testing by reviewing the applicable test
  • methods, and calculate number of samples required per study based on pack types
  • and storage conditions
  •  Assign stability study identification numbers and stability sample
  • quantities/storage condition for batch records that include procedures for stability
  • sampling
  •  Review specification changes for product, API, and packaging components to
  • assess impact to Regulatory Stability Protocols and revise protocols as needed
  • using appropriate change management systems.

Study Scheduling and Implementation

  •  Maintain schedule of stability pulls, and testing deadlines.
  •  Dispose of samples when study is completed or discontinued
  •  Participate in stability improvement projects
  •  Ensure samples are labeled properly and distribute to appropriate stability
  • chamber(s) for storage
  •  Monitor stability chambers and chart recorders daily to confirm environmental
  • conditions for acceptance with established specifications.
  •  Assist with the filing and archiving of stability studies.
  •  Additional duties as required

The essential functions of this role include:

  • wearing steel toe shoes

Skills

  • Communication
  • Quality Assurance
  • Inspection
  • Multi-tasking
  • Prioritizing
  • Decision Making
  • Documentation of Operations

Qualifications

  • Years of experience: 4 years
  • Experience level: Experienced

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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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