QC Specialist

QC Specialist

• First Shift, Mon-Fri
• $65,000 - $85,000 annual compensation
• Excellent Benefits Package
• Must be willing to follow FDA, CDC, EPA and OSHA guidelines

Position Summary:

The QC Specialist will support the entire range of quality control activities. Perform in-process and release testing, conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, and stability samples. Perform qualification/validation of QC assays. Perform maintenance of all QC laboratory equipment, and support transfer of methods to QC lab. Maintain accurate and concurrent testing records, interpret results, analyze trends, and report findings to the head of quality control and other departments as needed. Review paperwork of other specialists to ensure accuracy prior to submission to QA.

Responsibilities:

• Log in samples received into the QC Laboratory and provide support for shipping samples to other testing organizations
• Use cell culture aseptic techniques. Perform cell immunoassays and based assays: such as flow cytometry, Elispot, Luminex, ELISA, as well as PCR-based assays
• Support the maintenance of the material and reagent inventory within the laboratory and ensure appropriate cycle counts to re-order supplies
• Maintain equipment logbooks and support the maintenance and calibration of equipment
• Assist in the laboratory cleaning schedule
• Perform cell culture, media preparation, and preparation of solutions and reagents
• Responsible for raw material restocking, ordering, and performing checks on reagent expirations
• Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods and stability samples.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• Perform visual inspection of finished products.
• Compile laboratory test data and perform appropriate analyses.
• Complete documentation needed to support testing procedures, including data capture forms, equipment logbooks, or inventory forms.
• Calibrate, validate, and maintain laboratory equipment.
• Participate in out-of-specification and failure investigations and recommend corrective actions.
• Receive and inspect raw materials.
• Investigate or report questionable test results.
• Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
• Ensure that lab cleanliness and safety standards are maintained.
• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
• Train other specialists to perform laboratory procedures and assays.
• Identify and troubleshoot equipment problems.
• Participate in internal assessments and audits as required.
• Evaluate analytical methods and procedures to determine how they might be improved.
• Write technical reports or documentation, such as deviation reports, testing protocols, and trend analyses.
• Review data from contract laboratories to ensure accuracy and regulatory compliance.
• Coordinate testing with contract laboratories and vendors.
• Write or revise standard quality control operating procedures.
• Develop and qualify new testing methods.
• Prepare or review required method transfer documentation including technical transfer protocols or reports.
• Assist in training of new hires and retraining of QC laboratory staff, as needed.
• Completing any other relevant duties and responsibilities assigned by senior management.
• Ability to work on weekends or in rotating shifts if needed.

Qualifications:

• Bachelor's Degree in Life Sciences discipline; or relevant experience in the fields of Biotech/Pharma/Cell Therapy.
• 1-3 years’ experience in a cGMP analytical lab environment
• Experienced in Method Transfer preferred
• Experience in quality control of cells from human tissue origin preferred.
• Experience in current Good Manufacturing Practice (cGMP) environment preferred.
• Organizational, multitasking, problem-solving, math, statistical, interpersonal, written and oral communication skills. Detail-oriented and ability to prioritize work.
• Must be able to work within multi-functional teams.
• Ability to function well in a fast-paced environment.
• Strong manual dexterity
• Can easily work with little supervision
• Can lead a shift on occasion with confidence and competence
• High level of concentration and takes satisfaction in performing tasks with a high level of accuracy
• Good manual dexterity and mechanical aptitude
• Can easily read and interpret work instructions with a high level of accuracy
• Can easily fill out forms accurately and clearly.
• Identify mistakes and defects in workmanship
• Can easily anticipate problems before they occur
• Ability to communicate with all levels of staff clearly and do so professionally
• Can easily use tools and equipment
• Enjoy continually improving your skills
• Basic computer skills
• Must be able to read, write and understand English
• Ability to provide legal US work authorization documents required

Personal Attributes:

• Team player
• Do the right thing, even when no one is looking
• Great listener
• Accuracy is important
• Attention-to-detail
• Reliable
• Multitasker
• Critical thinking
• Strong team and interpersonal communication
• Quality focus
• Can work at a fast pace
• Even tempered
• Well organized
• Enjoys learning
• Conscientious
• Always conduct yourself with a high level of professionalism in our quest to save lives

Company Information

Cell Ready is a privately held contract development and manufacturing organization in Houston Texas, which makes cell and gene therapy drug products that provide incredible results for cancer patients.

With each drug product that we create, we provide cancer patients with a potential cure.

Due to the high market response to our groundbreaking approach to cell and gene therapy manufacturing, Cell Ready is expanding to a 70,000 sq. ft. facility and is increasing the size and competencies of its staff.

We are seeking a QC Specialist candidate that has a proven history of routinely making others around them better, taking on hard challenges and making them look easy, and consistently rising to any occasion.

Reasons to Apply:

• You will be an instrumental part of a team that will play a critical role in providing society with widespread access to Cell and Gene Therapies, which many believe is one of the most important advances in the history of cancer treatment.
• Cell Ready is a well-funded company with no debt.
• This combination of meaningful work and exceptional compensation is a rare opportunity.