Associate Quality Control Analytical

Job Description:

Associate, Quality Control Analytical, Cell Therapy
Rockville, MD

Summary

The Associate, QC Analytical, supports cGMP lot release and stability testing for cell therapy products by preparing samples and reagents, accomplishing test methods, operating instruments per SOPs, and maintaining accurate documentation. The role focuses on learning and performing routine activities with high quality and data integrity, assisting with lab maintenance and inventory, and supporting QC operations to meet timelines.

Role Responsibilities:

* Complete assays under supervision (e.g., automated cell counting, viability, ELISA, PCR, flow cytometry, basic cell culture handling) following approved methods and cGMP/GDP expectations.
* Prepare reagents, controls, and standards; perform sample receipt, labeling, and chain-of-custody according to SOPs.
* Operate assigned instruments per SOPs including daily checks, calibrations, and routine maintenance.
* Record data contemporaneously in relevant electronic systems; ensure completeness, accuracy, and compliance with ALCOA+ principles.
* Maintain inventory of consumables and reagents; perform lab housekeeping, 5S, and equipment cleaning; support sample logistics and courier/chain-of-custody processes.
* Assist in documenting deviations and events; provide data and observations for investigations (e.g., OOS/OOT); follow implemented CAPAs and change controls.
* Complete method training and analyst qualifications; maintain proficiency through periodic reassessments; seek feedback and demonstrate continuous learning.
* Communicate testing status, material needs, and issues to the team; support scheduling and sample coordination to meet lot release timelines.

Minimum Requirements:

* Associate's degree with three (3) years of relevant lab experience.
* Laboratory experience in a pharmaceutical/biotech or related academic setting. Exposure to QC, cGMP environments, or regulated documentation is a plus.
* Hands-on experience with laboratory techniques relevant to cell therapy or biologics (e.g., pipetting, aseptic technique, ELISA basics, PCR setup, cell counting/viability).
* Understanding of core cGMP concepts, Good Documentation Practices, and laboratory compliance; ability to follow SOPs precisely and ask clarifying questions.
* Strong focus on right-first-time execution, accurate record-keeping, and timely escalation of discrepancies.
* Demonstrates effective cross-functional collaboration, embraces flexibility in a constantly evolving environment, and maintains a positive, solutions-oriented attitude to drive outcomes.
* Enthusiasm to develop new technical skills and expand responsibilities with experience.
* Ability to work on-site in a lab-based role; willingness to support off-hours/weekend testing as needed to meet patient supply timelines.
* This role will require occasional weekend support.

Preferred Qualifications:
* Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, or related discipline with at least three (3) months of industry internship experience.

The annual base pay (or hourly rate of compensation) for this position ranges from $ 55,920.80 - $83,881.20 Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted24-Apr-2026

Closing Date29-Apr-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form