QC Sample Management (LIMS, cGMP, Documentation)

Aequor

Holly Springs (NC)

On-site

USD 65,000 - 90,000

Full time

3 days ago
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Job summary

Aequor is seeking a Quality Control Senior Associate in Holly Springs, NC for a 12-month contract (W2), fully onsite. The role starts with dayshift training (4/10) for 3–6 months, then transitions to a 4/10 night shift from 10:00 PM to 8:00 AM.

The associate will support sample management, testing across chemistry, bioassay, and microbiology, ensuring GDP/GMP compliance. Key duties include logging samples in LIMS, sampling storage and chain-of-custody, performing routine analyses, documenting

Qualifications

  • Associate degree in a scientific discipline or equivalent experience.
  • 1–3 years in a laboratory or sample management role.
  • Familiarity with LIMS or similar systems.
  • Willingness to work night shifts on a 4/10 schedule.

Responsibilities

  • Receive and log samples into LIMS and ensure proper labeling.
  • Maintain storage areas and chain-of-custody documentation.
  • Perform analytical testing across bioassay, chemistry, and microbiology.
  • Document results to GDP/GMP standards and support audits.
  • Maintain and calibrate laboratory equipment and assist investigations.
  • Collaborate with QC, QA, and cross-functional teams to meet milestones.

Skills

LIMS familiarity
Sample management
Analytical testing
Night shift availability

Education

Associate degree in science
Bachelor's degree preferred

Tools

LIMS
HPLC
ELISA
Incubators

Job description

Job Title: Quality Control Senior Associate
Location: Holly Springs NC (100% Onsite)
Duration: 12 Months with possible extension
Terms: Contract W2
Description:
Note:

Fully Onsite

All candidates must be available to work on night shift schedule after training

1st 3 - 6 months will be dayshift (training) - 4/10 schedule

After the training it will be 4/10-night shift schedule

Job Summary:

The associate will begin training in sample management the first 3 - 6 months, 4/10-day shift schedule with cross-training to support additional laboratory areas, including chemistry, bioassay, and microbiology.

The long term expectation will require the associate to work a 4/10-night shift schedule (Sunday–Wednesday or Wednesday–Saturday) from 10:00 PM to 8:00 AM.

The Associate, Quality Control supports sample management and laboratory testing activities within the Quality Control department. This role is responsible for the receipt, handling, tracking, storage, and disposal of samples used in analytical testing, while ensuring compliance with internal SOPs, regulatory requirements, and good documentation practices. The associate will collaborate closely with laboratory analysts, Quality Assurance, and other cross-functional teams to maintain efficient and accurate testing workflows.

Key Responsibilities:
  • Receive and log incoming samples into the Laboratory Information Management System (LIMS).
  • Ensure proper labeling, storage, and chain-of-custody documentation for all samples.
  • Perform Analytical Testing: Prepare and execute routine and complex testing procedures for bioassay, chemistry, and microbiology following established protocols and regulatory standards.
  • Evaluate and Document Results: Accurately record data, assess results for compliance with specifications, and ensure documentation meets GDP and GMP requirements.
  • Troubleshoot and Resolve Issues: Identify technical issues during testing and elevate or resolve them using defined procedures; collaborate with senior staff for complex problems.
  • Maintain Laboratory Equipment: Operate, calibrate, and perform basic maintenance on laboratory instruments (e.g., HPLC, ELISA platforms, microbiological incubators) to ensure readiness for testing.
  • Support Investigations and Audits: Participate in laboratory investigations related to out-of-specification results or deviations; provide supporting documentation during audits.
  • Cross-Functional Collaboration: Work closely with analysts and team leads across QC areas to meet project milestones and testing timelines.
  • Continuous Improvement: Suggest process improvements and contribute to efficiency initiatives within QC labs.
  • Compliance and Safety: Adhere to all safety guidelines, SOPs, and regulatory requirements while performing testing and handling hazardous materials.
Qualifications:
  • Associate degree in a scientific discipline or equivalent experience; Bachelor’s degree preferred.
  • 1–3 years of experience in a laboratory or sample management role.
  • Familiarity with LIMS or other sample tracking systems preferred.
  • Strong attention to detail and organizational skills.
  • Ability to work in a fast-paced, regulated environment.
  • Good communication and teamwork skills.
  • Available to work night shifts (10 PM – 8 AM) on a 4/10 schedule.
Top 3 Must Have Skill Sets:
  • Ability to handle samples and perform basic laboratory tasks with precision.
  • Familiarity with LIMS and documentation systems.
  • Understanding of SOPs, GDP, and safety protocols to ensure compliance.
Day to Day Responsibilities:
  • Receive, inspect, and log samples; verify integrity and documentation.
  • Assign IDs in LIMS and prepare samples for testing (aliquoting, labeling, storage).
  • Maintain storage areas per SOPs; monitor conditions and perform inventory checks.
  • Complete receipt/disposition forms; ensure GMP/SOP compliance and support audits.
  • Liaise with QC, manufacturing, and labs; manage pickups/deliveries and report issues.
  • Update sample data in LIMS; support process improvements and SOP reviews.
  • Follow safety protocols; keep areas organized and dispose of samples per procedures.
  • Chemistry: Perform routine chemical analyses (e.g., potency, purity) using validated methods.
  • Bioassay: Execute cell-based assays and maintain culture integrity for accurate results.
  • Microbiology: Conduct sterility and environmental monitoring tests per regulatory standards.
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