Associate Quality Control Analytical

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:

• Associates 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 solutionsoriented 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:

• Bachelors 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 $ 55920.80 - $83881.20 Our positions offer eligibility for various incentivesan 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 Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.