Quality Control Analyst

2 weeks ago

Houston, Texas, United States CellReady™ Full time

Quality Control Analyst

  • First Shift, Mon-Fri
  • $65,000 - $85,000 annual compensation
  • Comprehensive Benefits Package
  • Adherence to FDA, CDC, EPA, and OSHA regulations is required

Position Overview:

The Quality Control Analyst will engage in a broad spectrum of quality assurance activities. Responsibilities include conducting in-process and final product testing, performing routine and specialized analyses of in-process materials, raw materials, environmental samples, finished products, and stability assessments. The role also involves the qualification and validation of QC assays, maintaining all QC laboratory equipment, and facilitating method transfers to the QC lab. Accurate and timely documentation of testing records, result interpretation, trend analysis, and reporting findings to the quality control leadership and relevant departments are essential.

Key Responsibilities:

  • Register incoming samples in the QC Laboratory and assist with the logistics of sending samples to external testing facilities.
  • Utilize aseptic techniques in cell culture. Execute cell immunoassays and various assays, including flow cytometry, Elispot, Luminex, ELISA, and PCR-based methods.
  • Oversee the management of materials and reagent inventory in the laboratory, ensuring timely reordering of supplies.
  • Maintain equipment logbooks and support the upkeep and calibration of laboratory instruments.
  • Contribute to the laboratory cleaning schedule.
  • Conduct cell culture, media preparation, and the formulation of solutions and reagents.
  • Manage the restocking and ordering of raw materials, ensuring checks on reagent expiration dates.
  • Perform both routine and specialized analyses of in-process materials, raw materials, environmental samples, finished products, and stability samples.
  • Analyze test results, comparing them to established specifications and control limits, and provide recommendations regarding data appropriateness for product release.
  • Conduct visual inspections of finished products.
  • Compile laboratory testing data and perform necessary analyses.
  • Complete documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory records.
  • Calibrate, validate, and maintain laboratory equipment.
  • Engage in investigations of out-of-specification results and failures, recommending corrective actions.
  • Receive and evaluate raw materials.
  • Investigate or report any questionable test results.
  • Conduct validations or transfers of analytical methods in accordance with applicable policies or guidelines.
  • Ensure compliance with laboratory cleanliness and safety standards.
  • Monitor testing procedures to guarantee adherence to established specifications, standard test methods, or protocols.
  • Train other specialists in laboratory procedures and assays.
  • Identify and troubleshoot equipment issues.
  • Participate in internal assessments and audits as required.
  • Evaluate analytical methods and procedures for potential improvements.
  • Draft technical reports or documentation, including deviation reports, testing protocols, and trend analyses.
  • Review data from contract laboratories to ensure accuracy and compliance with regulations.
  • Coordinate testing activities with contract laboratories and vendors.
  • Draft or revise standard operating procedures for quality control.
  • Develop and validate new testing methodologies.
  • Prepare or review necessary documentation for method transfers, including technical transfer protocols or reports.
  • Assist in the training of new hires and the ongoing training of QC laboratory personnel as needed.
  • Perform any other relevant duties as assigned by senior management.
  • Willingness to work weekends or rotating shifts if necessary.

Qualifications:

  • Bachelor's Degree in a Life Sciences discipline or relevant experience in Biotech, Pharma, or Cell Therapy.
  • 1-3 years of experience in a cGMP analytical laboratory environment.
  • Experience in Method Transfer is preferred.
  • Background in quality control of cells derived from human tissue is preferred.
  • Experience in a current Good Manufacturing Practice (cGMP) environment is preferred.
  • Strong organizational, multitasking, problem-solving, mathematical, statistical, interpersonal, written, and verbal communication skills. Detail-oriented with the ability to prioritize tasks effectively.
  • Ability to collaborate within multi-functional teams.
  • Capability to thrive in a fast-paced environment.
  • Excellent manual dexterity.
  • Ability to work independently with minimal supervision.
  • Occasional leadership of a shift with confidence and competence.
  • High concentration levels and a commitment to performing tasks with precision.
  • Proficient in reading and interpreting work instructions accurately.
  • Ability to complete forms clearly and accurately.
  • Skilled in identifying mistakes and defects in workmanship.
  • Proactive in anticipating potential issues.
  • Effective communication with all staff levels in a professional manner.
  • Competent in using tools and equipment.
  • Desire to continuously enhance skills.
  • Basic computer proficiency.
  • Must be able to read, write, and comprehend English.
  • Legal authorization to work in the U.S. is required.

Personal Attributes:

  • Team-oriented.
  • Integrity and accountability.
  • Strong listening skills.
  • Commitment to accuracy.
  • Attention to detail.
  • Dependable.
  • Ability to multitask.
  • Critical thinking abilities.
  • Strong interpersonal communication skills.
  • Focus on quality.
  • Ability to work efficiently under pressure.
  • Even-tempered.
  • Highly organized.
  • Enthusiasm for learning.
  • Conscientiousness.
  • Professional demeanor in all interactions.

Company Overview:

Cell Ready is a privately held contract development and manufacturing organization dedicated to producing cell and gene therapy drug products that deliver remarkable outcomes for cancer patients.

Each drug product developed offers cancer patients a potential path to recovery.

In response to the significant market demand for our innovative approach to cell and gene therapy manufacturing, Cell Ready is expanding its operations to a larger facility and enhancing the capabilities of its workforce.

We are in search of a Quality Control Analyst who has a proven track record of elevating those around them, tackling challenging tasks with ease, and consistently rising to meet any challenge.

Benefits of Joining Us:

  • Be a vital part of a team that plays a crucial role in providing society with broader access to Cell and Gene Therapies, recognized as one of the most significant advancements in cancer treatment.
  • Cell Ready is a financially stable company with no debt.
  • This unique combination of meaningful work and competitive compensation presents a rare opportunity.

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