QC Sample Management (LIMS, cGMP, Documentation) at Aequor QC Sample Management (LIMS, cGMP, Documentation) at Aequor in Fuquay Varina, North Carolina Posted in 1 day ago.

Type:

full-time

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 escalate 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.