Pfizer Senior Aseptic Training Specialist in Rocky Mount, North Carolina

ROLE SUMMARY

The primary function of this job is to provide training to all Rocky Mount site employees in the Aseptic Certification Program. The Sr. Aseptic Trainer Specialist will be responsible for designing, scheduling, and executing all aseptic training. This training includes but is not limited to gowning, aseptic technique, and clean room behaviors. In addition, the Trainer will be responsible for scheduling and training aseptic personnel on TQ line for media fills. Also, the candidate is required to provide oversight on the manufacturing filling lines during media fills and to assist with investigation and CAPA implementation that are training related.

ROLE RESPONSIBILITIES

  • Design, schedule, and conduct training for all employees in the aseptic program

  • Oversee media fills on TQ and manufacturing filling lines

  • Lead the Aseptic Review Board (ARB) by compiling, tracking, trending, and presenting data related to the Rocky Mount aseptic program

  • Liaise with departments such as Operations, Biological Quality, and Manufacturing Quality as required to improve the aseptic training program

  • Perform necessary assessments of aseptic operation and update necessary documents.

  • Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing.

  • Assist with investigation and CAPA implementation

  • Ensure existing colleagues maintain aseptic certifications by scheduling and performing training when necessary in addition to maintaining necessary records

  • Work with other Pfizer sites and center function to develop and implement any new training in alignment with current industry standards/regulatory observations

  • Work with Aseptic Compliance Supervisor and Biological Quality to remediate any negative trends/observations

  • Complete assigned projects to improve site compliance in aseptic manufacturing

  • Perform other related duties as assigned or required

QUALIFICATIONS

  • Bachelor's Degree in a science, engineering or education field, such as Microbiology required with a minimum of 2 years of pharmaceutical manufacturing experience, aseptic experience preferred

  • 1+ year experience in a previous training or teaching role preferred

  • 1-2 years of supervisory experience preferred

  • Requires strong oral, written, communication, presentation, interpersonal and public speaking skills

  • Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site from an aseptic standpoint

  • Thorough knowledge of GMP's and expertise in aseptic processing preferred. Must have the ability to handle multiple projects in a dynamic environment

  • Must be able to assess training needs for individuals and areas

  • Must be able to edit and/or develop training modules

  • Must have demonstrated facilitation experience

  • Must possess and demonstrate oral and written communication skills

  • Ability to interface with all levels of employees

  • Prior experience in designing/delivering training programs

  • Thorough understanding of GMP's and how they are applied through the company specifications and procedures

  • Must have experience using a variety of computer software packages. Use of Powerpoint, and PLS is preferred

  • Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis

  • Must be able to work on weekend, off shifts and holiday as business demands

PHYSICAL/MENTAL REQUIREMENTS

  • Must be able to function under a stressful situation while being able to remain focused at the necessary requirements.

  • Must be able to appropriately identify and escalate issues on a timely basis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Must be able to work on weekend, off shifts and holiday as business demands.

ORGANIZATIONAL RELATIONSHIPS

  • Encompasses responsibility for the implementation of key aseptic principles, drive accountability and support GMP requirements in manufacturing. This position requires the incumbent to assess situations in relation to regulatory requirements, site and corporation requirements.

  • Independent action and sound decision-making are essential for success in the position as decisions made can impact short and long-term site objectives. Must be able to simplify complex matters and be able to present with clarity and thoughtfulness.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Other Job Details:

  • Last Date to Apply for Job: August 27, 2018

  • Eligible for Relocation Package

  • Eligible for Employee Referral Bonus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.