QA Specialist

2 weeks ago

Frederick, United States Cartesian Therapeutics Full time

**Summary**:
The QA Specialist reporting to Senior Director, QA will support manufacturing operations from clinical to commercial day to day, reviewing batch records, review documents for manufacturing teams to resolve issues and ultimately review and release batches. This person will have a high level of organization skills and be a critical thinker possessing a willing and able to pitch in where needed perspective and approach.

**Principal **Duties/Responsibilities**:

- Quality supporting manufacturing operations - Clinical to start and in the future commercial - day to day, continuing review of batch records, reviewing documents for manufacturing teams to resolve any quality issues and ultimately review and release batches
- Assist in implementing and maintaining the quality systems programs including but not limited to:

- Deviation management
- Change control
- Corrective and preventative action
- Material controls/material management
- Conduct batch record review for clinical and commercial product manufacturing
- Maintain approved labeling materials and process/distribute per company procedures
- Under limited direction and supervision, create, review, and revise standard operating procedures
- Support and contribute to quality improvement initiatives
- Participate in team meetings and make recommendations related to changes in processes, process improvements and provide suggestions as needed
- Assist in the internal audits as required
- Other duties, as assigned

**Qualifications**:

- Bachelor's degree, required
- Minimum 3-5 years of relevant pharmaceutical, biotechnology or medical device industry experience
- Background in one or more specialties of biotechnology: bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, cell biology, chemical engineering, and/or biochemical engineering
- Experience executing validations plans and reviewing validation protocols, reports and technical documents.
- Process Excellence training, preferred
- ASQ certification, preferred
- Familiarity with inspection methods and techniques, preferred
- Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment, preferred
- May be required to work evenings, off-hours, holidays or extended periods of time
- Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines

**Work **Environment**:
The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.

  • QA Specialist

    2 months ago

    Frederick, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryThe QA Specialist reporting to Senior Director, QA will support manufacturing operations from clinical to commercial day to day, reviewing batch records, review documents for manufacturing teams to resolve issues and ultimately review and release batches. This person will have a high level of organization skills and be a...

  • QA Specialist

    3 weeks ago

    Frederick, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryThe QA Specialist reporting to Senior Director, QA will support manufacturing operations from clinical to commercial day to day, reviewing batch records, review documents for manufacturing teams to resolve issues and ultimately review and release batches. This person will have a high level of organization skills and be a...

  • QA Calibration Specialist

    1 month ago

    Frederick, United States Frederick National Laboratory for Cancer Research Full time

    QA Calibration Specialist Job ID: req3960Employee Type: nonexempt full-timeDivision: Clinical Research ProgramFacility: Frederick: G-WAYLocation: 7116 Geoffrey Way, Frederick, MD 21704 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos...

  • QA Calibration Specialist

    3 weeks ago

    Frederick, United States Frederick National Laboratory for Cancer Research Full time

    QA Calibration Specialist Job ID: req3960Employee Type: nonexempt full-timeDivision: Clinical Research ProgramFacility: Frederick: G-WAYLocation: 7116 Geoffrey Way, Frederick, MD 21704 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos...

  • QA Calibration Specialist

    1 month ago

    Frederick, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    QA Calibration SpecialistJob ID: req3960Employee Type: nonexempt full-timeDivision: Clinical Research ProgramFacility: Frederick: G-WAYLocation: 7116 Geoffrey Way, Frederick, MD 21704 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos...

  • QA Calibration Specialist

    1 week ago

    Frederick, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    QA Calibration SpecialistJob ID: req3960Employee Type: nonexempt full-timeDivision: Clinical Research ProgramFacility: Frederick: G-WAYLocation: 7116 Geoffrey Way, Frederick, MD 21704 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos...

  • QA Calibration Specialist

    2 days ago

    Frederick, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    QA Calibration SpecialistJob ID: req3960Employee Type: nonexempt full-timeDivision: Clinical Research ProgramFacility: Frederick: G-WAYLocation: 7116 Geoffrey Way, Frederick, MD 21704 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos...

  • Quality Assurance Specialist III/IV

    4 days ago

    Frederick, United States AstraZeneca Full time

    Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to...

  • Quality Assurance Specialist Iii/iv

    3 weeks ago

    Frederick, United States AstraZeneca Full time

    Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to...

  • Receiving Specialist

    4 weeks ago

    Frederick, United States Precision Medicine Group Full time

    The Receiving Specialist will work in an organized manner to accurately receive Shipments of materials/product in order to maintain the integrity of inventory control, and insure the delivery of materials/product to the proper department.Essential functions of the job include but are not limited to: Unload, Receive and Sign for incoming PackagesReconcile...

  • Receiving Specialist

    1 month ago

    Frederick, United States Precision Medicine Group Full time

    The Receiving Specialist will work in an organized manner to accurately receive Shipments of materials/product in order to maintain the integrity of inventory control, and insure the delivery of materials/product to the proper department. Essential functions of the job include but are not limited to: * Unload, Receive and Sign for incoming Packages *...

  • Receiving Specialist

    2 weeks ago

    Frederick, United States Precision Medicine Group Full time

    The Receiving Specialist will work in an organized manner to accurately receive Shipments of materials/product in order to maintain the integrity of inventory control, and insure the delivery of materials/product to the proper department. Essential functions of the job include but are not limited to: * Unload, Receive and Sign for incoming Packages *...

  • Receiving Specialist

    3 weeks ago

    Frederick, United States Precision Medicine Group Full time

    The Receiving Specialist will work in an organized manner to accurately receive Shipments of materials/product in order to maintain the integrity of inventory control, and insure the delivery of materials/product to the proper department.Essential functions of the job include but are not limited to: Unload, Receive and Sign for incoming PackagesReconcile...

  • Receiving Specialist

    2 weeks ago

    Frederick, United States Precision Medicine Group Full time

    Receiving Specialist at Precision Medicine Group (View all jobs) Frederick, MD, USA The Receiving Specialist will work in an organized manner to accurately receive Shipments of materials/product in order to maintain the integrity of inventory control, and insure the delivery of materials/product to the proper department. Essential functions of the job...

  • Quality Assurance Specialist Ii

    4 weeks ago

    Frederick, United States AstraZeneca Full time

    Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to...

  • Receiving Specialist

    1 month ago

    Frederick, United States Precision for Medicine Full time

    The Receiving Specialist will work in an organized manner to accurately receive Shipments of materials/product in order to maintain the integrity of inventory control, and insure the delivery of materials/product to the proper department. Essential functions of the job include but are not limited to: Unload, Receive and Sign for incoming Packages Reconcile...

  • Receiving Specialist

    3 weeks ago

    Frederick, United States Precision for Medicine Full time

    The Receiving Specialist will work in an organized manner to accurately receive Shipments of materials/product in order to maintain the integrity of inventory control, and insure the delivery of materials/product to the proper department. Essential functions of the job include but are not limited to: Unload, Receive and Sign for incoming Packages Reconcile...

  • Quality Assurance Specialist

    1 week ago

    Frederick, Maryland, United States Chimera Enterprises International Full time

    . Chimera Enterprises International is seeking a Quality Assurance Specialist to support the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO- CBRND) JPEO-CBRND Medical Office. The JPEO-CBRND manages our nations investments in chemical, biological, radiological, and nuclear defense equipment, and medical...

  • QAulity Assurance Specialist Ii

    4 weeks ago

    Frederick, United States AstraZeneca Full time

    **Job Description**: Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct...

  • Sr. Biodefense Regulated Quality Review Specialist

    1 month ago

    Frederick, United States Alakaina Family of Companies Full time

    The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Senior Biodefense Regulated Quality Review Specialist to support our contract with USAMRIID in Frederick, Maryland. The candidate shall provide Quality Review (QR) Specialist support, to include 100% reviews of data, spreadsheets, tables, listings, figures, etc., as well as SEND...