CGMP Biomanufactuirng Training Specialist

About the role

This position works with the Training Manager, cGMP Biomanufacturing to organize and present in-person training sessions on SOPs, cGMP processes, compliance and Environmental Health and Safety to the cGMP BioManufacturing Group.

Responsibilities

• Track/monitor training and provide timely, accurate information and reports to the Training Manager including metrics actions needed to ensure compliance
• Lead training sessions
• Conduct needs assessment to determine training requirements
• Address learning issues, instruction problems, or new educational needs regarding specific employees or groups
• Develop and administer training programs for employees
• Revise materials based on assessment/evaluation findings/outcomes
• Collaborate with Subject Matter Experts to identify need, target audience and desired performance standards
• Provide on the floor manufacturing support
• Assist Quality Assurance department with SOP training as needed
• Track/review training records for accuracy and completeness
• Inform personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results
• Maintain effectiveness of Quality system as it pertains to cGMP and training requirements
• Absorb and maintain cleanroom housekeeping and adhere to 5S standards
• Execute equipment qualification/validation protocols, as required
• Perform other duties as assigned

Requirements

• Ability to work within ISO 6/7/8 clean room environments
• Ability to use Excel, Word, and other MS Office applications
• Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy
• Ability to peer review data to ensure data is well organized with complete documentation
• Ability to understand and independently apply cGMPs to everyday work with regards to documentation and equipment use
• Ability to operate within a clean room environment (ISO 6/7/8) and provide on the floor support

Qualifications

• B.S./B.A. in Biology, Chemistry or other related scientific field, with minimum of 1-2 years’ experience in related laboratory work

Skills

• BioManufacturing or other Pharmaceutical/Medical Device experience
• Clean room, aseptic technique, and/or general lab equipment experience
• cGMP, Good documentation practices (GDP), Good Laboratory Practices (GLP) knowledge

Benefits

• Exposure to a variety of career opportunities as a result of our expansive network of client companies
• Access to more than 3,000 online training courses through our Kelly Learning Center
• Weekly pay and service bonus plans
• Group-rate insurance options available immediately upon hire
• Retirement savings plan
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
• Transit spending account

Pay

$29.81 /HR

Schedule

MON-FRI 8AM - 5PM