Quality Control Analyst

Cellares; Bridgewater (MA); On-site; USD 90,000 - 210,000; Full time

Benefits offered by this job

Stock options

Onsite lunches

Medical, Dental, Vision plans

401(k) Matching

Job summary

Cellares in Bridgewater, NJ is seeking a Quality Control Analyst to perform routine and non-routine analytical testing in a cGMP environment, including in-process, raw material, release, and stability assays, to support manufacturing and regulatory submissions.

The role reports to the Senior Director, Quality Control Bioanalytics and requires hands-on execution, data review, method validation, and training of staff.

Qualifications

• Bachelor's degree in science required.
• 2+ years in cGMP at an operational level.
• Experience in method development/validation.
• Experience with cell therapy assays (qPCR/dPCR/flow cytometry) preferred.
• Knowledge of pharmaceutical cGMP (US/EU) preferred.
• Excellent verbal, written, interpersonal, and organizational skills.
• Must be able to commute to Bridgewater, New Jersey.

Responsibilities

• Conduct routine and non-routine analytical testing of in-process materials, raw materials, finished goods, and stability samples.
• Perform cell therapy assays (qPCR, dPCR, flow cytometry) and related analyses.
• Prepare COA/COT for testing performed.
• Review analytical results and investigate OOS/OOT deviations.
• Participate in validation and transfer of analytical methods.
• Write and revise test methods and stability protocols.
• Maintain training records and provide trainer support.
• Assist in audits and quality systems activities.
• Support equipment validation and calibration.
• Supply data for regulatory submissions.

Skills

cGMP compliance

method development

flow cytometry

dPCR

qPCR

analytical testing

communication

Education

Bachelor's degree in science

Tools

qPCR instruments

Flow cytometer

dPCR instruments

Job description

We are seeking an innovative, creative, and detail-oriented Quality Control Analyst to join our team in Bridgewater, New Jersey. This position will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs). This role supports the day-to-day operations within the Quality Control group via execution of analytical testing. This includes but is not limited to in-process testing, lot release testing, stability testing, and raw material testing. All activities are performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.

This role will be a hands‑on resource reporting to the Senior Director, Quality Control Bioanalytics.

Candidates should enjoy working in a fast‑paced, mission‑driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

• Conduct routine and non‑routine analytical, biochemical, and/or biological analysis such as, in-process materials, raw materials, finished goods, or stability samples
• Work with cell therapy products and associated assays (dPCR, qPCR, cell‑based potency assays, proliferation assays, ELISA, flow cytometry assays, etc.)
• Perform timely and accurate peer review of analytical test results/reports
• Prepare COA/COT for testing performed
• Identify discrepancies, initiate and investigate OOS/OOT results for phase 1 and phase 2
• Initiate and investigate deviations related to quality control
• Compile and review data to ensure accuracy and regulatory compliance
• Support development for specifications and justification of specifications
• Participate in validation and technical transfer of analytical methods commensurate with experience
• Write and revise test methods
• Maintain required training and training records and provide training to qualify other associates
• Participate in internal assessments and audits as required
• Support equipment validation, calibration, maintenance, and troubleshooting
• Write method validation protocol/reports and other documentation such as test reports
• Write stability protocol and stability reports
• Write and revise Quality Control Standard Operating Procedures
• Supply Quality Control data necessary for regulatory submissions
• Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc.
• Assist in general upkeep of the laboratory and maintain a clean work environment
• Perform other duties as assigned

Requirements

• Bachelor's degree in a science discipline required, or comparable experience
• 2+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment, is preferred
• Prior experience related to method development/validation
• Prior experience with immune cell phenotyping by multicolor flow cytometry, dPCR, qPCR, cell-based potency and other cell therapy related assays is preferred
• Knowledge of pharmaceutical cGMP (US and EU) is preferred
• Must have excellent verbal, written, interpersonal, and organizational and communication skills
• Must be able to commute to Bridgewater, New Jersey
• Self‑awareness, integrity, authenticity, and a growth mindset

$90,000 - $210,000 a year

Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.