Aseptic Compliance Trainer

Pfizer • Rocky Mount, NC

7d • Onsite

About The Position

Use Your Power for Purpose Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer’s mission. You will play a crucial role in improving patients' lives by ensuring that our team is well-trained and compliant with Good Manufacturing Practices (GMP). Your efforts ensure that patients and physicians have timely access to the medicines they need. What You Will Achieve In this role, you will: Responsible for owning and implementing CAPAs for the Aseptic Compliance and Training department Develop and implement curricula, procedures and pertinent documents to address the skills and behaviors required to ensure that the sterile manufacturing areas(s) operate in compliance Maintain working knowledge of Good Manufacturing Practices and emerging regulatory and compliance concerns. Provide recommendations for improvements in the sterile manufacturing training program trainings regularly in order to ensure Continuous Improvement loop. Deliver EM training to all EM analysts, including sampling of production areas and processing of utility samples, environmental samples, and commodities. Deliver training on the appropriate use of EM equipment and SOP’s. Aseptic technique will be utilized for sample collection as required per standard operating procedures. Deliver sterile manufacturing training to all new colleagues/continent workers and current operations colleagues (when required). Train all operations colleagues annually on sterile manufacturing refresher training. Maintain accurate, complete, and legible records. May utilize Laboratory Information Management Systems (LIMS), Mobile Data Acquisition, (MODA) or other electronic record systems. Complies with all Safety, Environmental, and Security policies as required. Communicate all safety concerns, incidents, and events as they occur.

Requirements

• BA/BS degree with any years of experience, or Associate's degree with 4+ years of experience, or high school diploma (or equivalent) with 6+ years of relevant experience
• Excellent communication skills, both oral and written
• Solid understanding of GMP and Regulatory Training compliance
• Experience in Technical Training Skills
• Proficiency in MS Office, especially Word and PowerPoint
• Strong organizational and time management skills

Nice To Haves

• A solid understanding of manufacturing processes and regulatory compliance
• Strong problem-solving skills and attention to detail
• Ability to adapt to changing priorities and manage multiple tasks
• Experience in developing and delivering training programs
• Strong interpersonal skills and the ability to work effectively with diverse teams
• Demonstrated ability to lead and mentor others
• Ability to work in fast past, high pressure environment.
• Be able to be on your feet for extended periods while conducting trainings sessions.
• Ability to work nonstandard hours/shifts to meet business needs.

Responsibilities

• Responsible for owning and implementing CAPAs for the Aseptic Compliance and Training department
• Develop and implement curricula, procedures and pertinent documents to address the skills and behaviors required to ensure that the sterile manufacturing areas(s) operate in compliance
• Maintain working knowledge of Good Manufacturing Practices and emerging regulatory and compliance concerns.
• Provide recommendations for improvements in the sterile manufacturing training program trainings regularly in order to ensure Continuous Improvement loop.
• Deliver EM training to all EM analysts, including sampling of production areas and processing of utility samples, environmental samples, and commodities.
• Deliver training on the appropriate use of EM equipment and SOP’s.
• Aseptic technique will be utilized for sample collection as required per standard operating procedures.
• Deliver sterile manufacturing training to all new colleagues/continent workers and current operations colleagues (when required).
• Train all operations colleagues annually on sterile manufacturing refresher training.
• Maintain accurate, complete, and legible records.
• May utilize Laboratory Information Management Systems (LIMS), Mobile Data Acquisition, (MODA) or other electronic record systems.
• Complies with all Safety, Environmental, and Security policies as required.
• Communicate all safety concerns, incidents, and events as they occur.

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 7,5% of the base salary
• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees