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August Bioservices, LLC · 9 hours ago

Aseptic Manufacturing Training Specialist

Nashville, Tennessee

Full-time

Onsite

Entry, Mid Level

2+ years exp

August Bioservices is a company focused on aseptic manufacturing, and they are seeking an Aseptic Manufacturing Training Specialist to support the manufacturing leadership team. The role involves delivering hands-on training to manufacturing employees and developing training programs to ensure compliance with industry standards.

BiotechnologyMedicalPharmaceutical

Responsibilities

Develop and execute training programs for manufacturing employees, including onboarding, technical skills development, safety protocols, and continuous improvement initiatives

Support the Manufacturing Training Manager in assessing training needs through collaboration with Manufacturing department leaders, job analyses, and employee feedback

Create training materials such as standard operating procedures (SOPs), work instructions, e-learning modules, and hands-on training exercises

Conduct training sessions in various formats, including classroom instruction, on-the-job training, and virtual learning

Maintain training records and documentation to ensure compliance with regulatory requirements and company policies

Evaluate the effectiveness of training programs through assessments, feedback, and performance analysis, making necessary adjustments to improve learning outcomes

Partner with subject matter experts (SMEs) and leadership to ensure training content remains up-to-date with industry best practices, technological advancements, and compliance regulations

Support a culture of continuous learning and professional development within the manufacturing team

Assist in audits and regulatory inspections by providing training documentation and demonstrating adherence to training protocols

Provide assistance during aseptic media fills, as needed

Qualification

Technical training developmentGMP knowledgeRegulatory complianceManufacturing processesQuality control principlesBasic computer skillsCommunication skillsOrganizational skillsAdaptability

Required

Experience in developing and delivering technical training programs

Good knowledge of GMP and Regulatory requirements as related to aseptic manufacturing

Strong understanding of manufacturing processes, safety standards, and quality control principles

Excellent communication, presentation, and interpersonal skills

Ability to adapt training methods to suit diverse learning styles and technical expertise levels

Detail-oriented with strong organizational and record-keeping abilities

Ability to work a non-standard Work Schedule as needed

Ability to work on weekends, off shifts and holidays as business demands

Basic computer skills, including familiarity with Microsoft Office Suite (Word, Excel, PowerPoint) and learning management systems (LMS)

Prolonged periods of standing in a manufacturing area or sitting at a desk and working on a computer

Must be able to lift up to 40 pounds at times

Able to gown for Grade A/B, Grade C/D and wear a respirator without any restrictions

Preferred

Bachelor's degree in Education, Engineering, Scientific field, or a related field preferred

2+ years of experience in training, quality assurance, or manufacturing role, within the pharmaceutical industry

Company

August Bioservices, LLC

August Bioservices, a leading sterile injectable CDMO headquartered in Nashville, Tennessee, delivers end-to-end contract development and manufacturing services for pharmaceutical and biotech clients.

Founded in 2017

Nashville, Tennessee, USA

51-200 employees