Training Program Manager, QA

1 week ago

Frederick, United States Cartesian Therapeutics Full time

**Summary**:
The Training Program Manager, QA reporting to the Senior Director, QA primary role will be to manage and build a training program for the Company. This person will be highly organized and enjoy teaching others and possess and demonstrate a customer service approach and perspective.

**Principal **Duties/Responsibilities**:

- Set up site training program (including Onboarding program: Quality, Safety, Documentation, etc.), work with departments to establish their training programs, including interface with SOP generation/revision processes
- Manages and grows the QA Training team responsible for administration of the cGMP
- Training program to include curricula organization and deployment, oversight of organizational training status in both local and enterprise learning management systems (LMS) and providing real-time training consultation to cross-functional stakeholders at an aseptic cell culture manufacturing facility.
- Collaborates closely with all department management at the AIRM location to determine training needs, establish training curriculums and assignments based upon work functions, and schedule training sessions.
- Partner with functional areas to conduct monitoring of training compliance status, efficiency checks, and trend results.
- Responsible for ensuring training on documentation and training related processes and procedures are performed according to defined expectations.
- Oversees the QA Training function. Ensures adequate systems are in place to achieve personnel training and qualification compliance with GMP quality expectations.
- Supplies regular metrics to management with relevant compliance insights, highlights and engages in continuous improvement opportunities.
- Provides coaching, mentoring, professional development, and performance management to junior Quality Assurance staff as appropriate.

**Qualifications**:

- BS degree in Engineering, Chemistry, Biological Sciences or equivalent with 8+ years or MS with 6+ years related experience in bio-pharma industry, and 2+ years of managerial experience in a cGMP compliance environment.
- Demonstrated experience with developing or delivering training to colleagues and/or managing a training program and LMS.
- Fluency in GMP training, document administration, and data integrity principles.
- Working knowledge of predicate regulations and industry consensus standards, including 21CFR -11, -210, -211, -1271; Eudralex Volume IV (including ATMPs), ICH Q9, Q10, etc.
- Experienced in identifying, proposing, and managing quality system improvement initiatives and projects.
- Advanced proficiency in MS Word, Excel, and PowerPoint.

**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 Manager-

    2 months ago

    Frederick, United States Latitude, Inc. Full time

    Job DescriptionJob DescriptionQA Manager duties are to include managing the QMS to make changes towards cGMP compliance with applicable sections of 21 CFR Regulations for medical devices and QA monitoring of manufacturing, quality, logistics and customer management processes. This position requires writing, reviewing and updating SOP’s. This position will...

  • QA Manager-

    4 weeks ago

    Frederick, United States latitude Full time

    QA Manager duties are to include managing the QMS to make changes towards cGMP compliance with applicable sections of 21 CFR Regulations for medical devices and QA monitoring of manufacturing, quality, logistics and customer management processes. This position requires writing, reviewing and updating SOP's. This position will require internal and external...

  • QA Associate

    4 weeks ago

    Frederick, United States Collabera Full time

    Description Home Search Jobs Job Description QA Associate Contract: Frederick, Maryland, US Salary: $27.00 Per Hour Job Code: 349124 End Date: 2024-06-06 Days Left: 9 days, 3 hours left Apply Position Details: Industry: Pharmaceuticals Job Title: QA Associate I Location: Frederick, MD Job Description:Summary: The QA Associate I provides essential...

  • QA Associate

    4 weeks ago

    Frederick, United States Collabera Full time

    Description Home Search Jobs Job Description QA Associate Contract: Frederick, Maryland, US Salary: $27.00 Per Hour Job Code: 349124 End Date: 2024-06-06 Days Left: 8 days, 3 hours left Apply Position Details: Industry: Pharmaceuticals Job Title: QA Associate I Location: Frederick, MD Job Description:Summary: The QA Associate I provides essential...

  • QA Associate

    4 weeks ago

    Frederick, United States Collabera Full time

    Description Home Search Jobs Job Description QA Associate Contract: Frederick, Maryland, US Salary: $27.00 Per Hour Job Code: 349124 End Date: 2024-06-06 Days Left: 6 days, 3 hours left Apply Position Details: Industry: Pharmaceuticals Job Title: QA Associate I Location: Frederick, MD Job Description:Summary: The QA Associate I provides essential...

  • QA Associate

    3 weeks ago

    Frederick, United States Collabera Full time

    Description Home Search Jobs Job Description QA Associate Contract: Frederick, Maryland, US Salary: $27.00 Per Hour Job Code: 349124 End Date: 2024-06-06 Days Left: 1 days, 3 hours left Apply Position Details: Industry: Pharmaceuticals Job Title: QA Associate I Location: Frederick, MD Job Description:Summary: The QA Associate I provides essential...

  • QA Associate

    3 weeks ago

    Frederick, United States Collabera Full time

    Description Home Search Jobs Job Description QA Associate Contract: Frederick, Maryland, US Salary: $27.00 Per Hour Job Code: 349124 End Date: 2024-06-06 Days Left: 2 hours left Apply Position Details: Industry: Pharmaceuticals Job Title: QA Associate I Location: Frederick, MD Job Description:Summary: The QA Associate I provides essential clerical...

  • QA Specialist

    1 week 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...

  • 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 Associate

    2 months ago

    Frederick, United States Leadstack Inc Full time

    **Job Title: QA Associate I** **Location: Frederick, MD-Onsite** **Duration: 3 months Contracts** **PR: $20- $28/hr on W2** M-F (exact days / hours worked to be confirmed with hiring manager during the interview process) **Description**: - Provides clerical and administrative support related to documentation processes and systems. - Creates logbooks and...

  • QA Associate I

    3 weeks ago

    Frederick, United States TekwissenLLc Full time

    **Position: QA Associate ILocation: Frederick, MDDuration: 3 Months Job Type: Contract Work Type: Onsite** **Description**: - Provides clerical and administrative support related to documentation processes and systems. Creates logbooks and other control issued documents. - Assists in maintaining the document archival room. - Responsible for filing and...

  • QA Associate I

    4 weeks ago

    Frederick, United States Integrated Resources, Inc Full time

    Job Title: QA Associate I Location: Frederick, MD Job Duration: 3 Months+ Pay Range: $27.27/hr on W2 Job Description: · Provides clerical and administrative support related to documentation processes and systems. · Creates logbooks and other control issued documents. · Assists in maintaining the document...

  • QA Associate I

    5 days ago

    Frederick, Maryland, United States TekwissenLLc Full time

    Position: QA Associate ILocation: Frederick, MDDuration: 3 Months Job Type:Contract Work Type: OnsiteDescription: Provides clerical and administrative support related to documentation processes and systems. Creates logbooks and other control issued documents. Assists in maintaining the document archival room. Responsible for filing and maintenance of...

  • QA Data Reviewer

    3 weeks ago

    Frederick, United States Modavar Pharmaceuticals LLC Full time

    Are you looking for a challenging role that allows you to contribute to innovation and data integrity?. If so, this role could be an ideal opportunity for you. As a QA Data reviewer, you will ensure the safety and integrity of quality data. The purpose of this position is to review all analytical data (raw and electronic) and support the release of raw...

  • QA Calibration Specialist

    4 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

    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

    6 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...

  • QA Calibration Specialist

    4 weeks 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...

  • Engineer III, QA

    3 weeks ago

    Frederick, Maryland, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, and you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry,...