Associate Quality Control

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 (SundayWednesday or WednesdaySaturday) 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; Bachelors degree preferred.
- 13 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.