Quality Control Analyst, Microbiology

Cellares

Cellares

IT, Quality Assurance
Bridgewater, NJ, USA
Posted on Saturday, May 4, 2024
We are seeking an innovative, creative, and detail-oriented Quality Control Analyst, Microbiology 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 Environmental Monitoring and microbiological 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 hands-on resource reporting to the Quality Control Manager, Microbiology. The level will be determined based upon the candidate’s education, skills, and/or related experience.
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 Environmental Monitoring of isolators and ISO 8 cleanrooms (non-viable and viable air particulate, surface viables) in a GMP manufacturing facility
  • Conduct Utilities Monitoring of compressed gas systems (non-viable and viable air particulate, dewpoint, hydrocarbons) in a GMP manufacturing facility
  • Conduct routine and non-routine microbiological testing of materials and cell therapy products (Gram stain, growth promotion, endotoxin, mycoplasma, sterility)
  • Prepare COA/COT for testing performed
  • Support method qualification and transfer
  • Write and revise Quality Control SOPs, protocols and reports
  • Perform timely and accurate peer review of test results/reports
  • 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 of microbiological methods commensurate with experience
  • 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
  • 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 laboratory and maintain a clean work environment
  • Perform other duties as assigned

Requirements

  • BA or B.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 with Environmental Monitoring and microbiological assays (endotoxin, mycoplasma, sterility)
  • 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
  • Excellent verbal, written, organizational, presentation and interpersonal skills
  • Self-awareness, integrity, authenticity, and a growth mindset
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.