What are the responsibilities and job description for the Quality Control Specialist - Sample Management Specialist position at Planet Pharma?
Quality Control Specialist - Sample Management Specialist
Location: Holly Springs, NC
Contract Duration: 1 Year
Target Pay Rate: $38/hr. (with flexibility)
Position Overview:
This critical role in the Sample Management Laboratory will involve hands-on leadership and execution of sample management activities, including sample handling, aliquoting, and maintaining chain of custody in a cGMP-compliant environment. The position demands an experienced candidate capable of supporting the startup and operation of the Sample Management and Stability Labs. This position is pivotal to the success of the lab and will involve a variety of key responsibilities.
Key Responsibilities:
- Lead and perform key Sample Management laboratory procedures, including:
- Sweeping samples from manufacturing
- Aliquoting cGMP samples in an aseptic environment
- Managing sample shipments (in and out)
- Contract Testing Laboratory (CTL) coordination and management
- Ensure proper handling and storage of samples, adhering to GMP standards
- Maintain specialized laboratory equipment and ensure operational readiness
- Implement and manage controlled document changes, including SOPs
- Document laboratory tasks within LIMS (Laboratory Information Management System)
- Support critical routine activities, including weekends and public holidays, as required
Required Qualifications:
- Educational Requirements:
- Doctorate degree, OR
- Master’s degree and 3 years of experience, OR
- Bachelor’s degree and 5 years of experience, OR
- Associate degree and 10 years of experience, OR
- High school diploma/GED and 12 years of experience in a related field
- Experience in managing cGMP samples, aliquoting, and working with sample management in manufacturing
- Proficiency with shipping and receiving GMP samples and familiarity with stability sample management
- Familiarity with documenting tasks in LIMS
Top Skills for Success:
- Extensive experience in Sample Management in a laboratory setting
- Knowledge of GMP compliance and SOPs related to sample handling
- Ability to establish and execute procedures for sample handling, storage, and shipment management
- Proficiency in documenting processes in LIMS
- Stability sample management experience is a plus
Additional Responsibilities:
- Assist in the procurement of consumables and critical reagents for laboratory startup
- Support the startup, qualification, and validation of Sample Management and Stability Laboratories within a GMP framework
- Assist with the development and implementation of standard operating procedures (SOPs) for sample management processes
- Assist with the ongoing support and operational readiness of the laboratory
Employee Value Proposition:
- Gain valuable experience at a new state-of-the-art site
- Opportunity for contract extension based on performance
- Play a critical role in the establishment of essential lab functions at a new site
Ideal Candidate Profile:
- 8-10 years of experience in a Sample Management role, ideally in a QC Sample Management Lab
- Experience in GMP compliance, sample aliquoting, shipping/receiving samples, and stability sample management
- Strong understanding of LIMS documentation and controlled document changes
- Ability to handle critical lab tasks in a highly regulated environment
Salary : $38
