Biomanufacturing Training Specialist

Responsibilities

• Track and monitor training, providing timely and accurate reports to the Training Manager.
• Actively lead training sessions and assist in conducting needs assessments.
• Collaborate with managers to address learning issues and new educational needs.
• Affiliate in developing qualifications and evaluations to ensure training effectiveness.
• Design and develop training on job-specific tasks, SOP training, FDA cGMP, and safety regulations.
• Revise training materials based on assessment findings.
• Partner with Subject Matter Experts to identify needs and desired performance standards.
• Provide on-the-floor manufacturing support and assist with SOP training as needed.
• Participate in team meetings and track training records for accuracy.
• Maintain the effectiveness of the Quality system related to cGMP and training requirements.
• Assist in cleanroom housekeeping and adherence to 5S standards.
• Execute equipment qualification/validation protocols as required.
• Perform other duties as assigned.

Qualifications

• B.S./B.A. in Biology, Chemistry, or a related scientific field.
• Minimum of 1-2 years of experience in related laboratory work.

Skills

• Experience in BioManufacturing or Pharmaceutical/Medical Device industries.
• Knowledge of clean room, aseptic techniques, and general lab equipment.
• Familiarity with cGMP, GDP, and GLP practices.
• Experience with standard operating procedures and equipment troubleshooting.
• Prior experience with ISO 6/7/8 cleanroom environments and dedicated training.
• Proficiency in electronic tracking software like Trackwise or ComplianceWire.
• Ability to work in ISO 6/7/8 cleanroom environments and use MS Office applications.
• Strong mathematical skills for data accuracy and peer reviews.
• Independent application of cGMPs in documentation and equipment use.

Pay

The typical base pay for this role across the U.S. is: $29.81 - $29.81 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.