Pfizer

Associate, Training Specialist

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Posted
November 25 2021
Ref
4831007
Discipline
Other, Other
Position Type
Full Time
Organization Type
Pharma
Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

The Training Specialist is responsible to oversee and coordinate training activities for the Andover Liquid Dose Manufacturing (AN-LDM) 1st and 2nd shift Operation groups. The individual is also responsible for the development, delivery, assessment, and maintenance of the AN-LDM training programs documentation (Read and Understand (R&U) and On the Job Training (OJT)) and courses within Power 2 Learn (P2L).
  • Responsible for ensuring high quality and efficient learning in support of aseptic manufacturing operations.
  • Collaborate with the manufacturing operations team to effectively design, develop, implement and coordinate aseptic learning programs in support of business goals and site practices.
  • Ensures that all colleagues and contingent workers are qualified to perform their GMP responsibilities by efficiently managing the training curriculum in Power 2 Learn (P2L).
  • Collaborate with AN-LDM management to effectively develop a robust training curriculum for all colleagues


How You Will Achieve It

  • Management & strategic coordination of aseptic training resources and communication with trainees regarding aseptic learning plans
  • Oversight & scheduling of assigned On the Job (OJT) training for the manufacturing operation groups
  • Ensure that adequate technical training programs are in place to develop colleagues per training curriculum and regularly evaluate the effectiveness of these training and development programs. Provide recommendations for improvement as see fit.
  • Ensure all necessary pre-requisite trainings are in place for all personnel.
  • Ensure that the training materials that require periodic retraining/requalification are managed effectively (inspection program and aseptic gowning).
  • Support AN-LDM Managers/Supervisors to accurately determine their team training curriculum or status prior to assigning GMP tasks.
  • Support Operations with executed BR operational review.
  • Responsible for acting as a liaison between the LDM managers/staff and the Training Point of Contact (TpoC).
  • Working with the TpoC and SMEs to ensure that training methodology and the need for a learning assessment is determined via documented risk analysis and effectively implemented for all SOPs and other related GMP training topics.
  • Maintain current knowledge of regulatory requirements and cGMP expectations for training.
  • Coach and support SME team members to ensure flexibility of operations and improve engagement and individual development/growth to optimize training skills.
  • Collaborate with Investigators when there is a human performance error learning category to drill down to root cause and apply effective CAPA associated with aseptic behaviors.
  • Maintain a list of qualified area trainers and SMEs to ensure that an effective Train-the-Trainer process is in place as needed.
  • Implement effective communication and alignment between TpoC and AN-LDM management regarding training.
  • Work with SMEs on SOP revisions to accurately generate OJT if required


Qualifications

Must-Have

  • High school diploma PLUS a minimum of 6 years or BA/BS Degree 0+ years of direct experience in aseptic manufacturing environment, including significant, demonstrated competence.
  • Have a sound understanding of GMPs and various types of training documentation (e.g. SOPs, User Guides, OJTs, training curricula)
  • Demonstrated practical application of theory, with enough credibility in day-to-day aseptic practice to be able to influence appropriate aseptic behaviors.
  • Have clear track record of effective teamwork, collaboration and communication, with demonstrated ability to work in a cross-functional team environment
  • Strong organizational and prioritization skills to handle multiple tasks


Nice-to-Have

  • BS in education, training and development, technical or science field; and/or demonstrated equivalent experience with proven success.
  • 5+ years direct experience in aseptic manufacturing and experience with aseptic manufacturing training.
  • Solid knowledge of Aseptic Behaviors and Techniques
  • Train the Trainer Certified
  • Demonstrated presentation skills to audience at various levels, with good written and verbal communication skills
  • Strong critical thinking and analytical skills with high attention to detail
  • Ability to manage change and deal with ambiguity
  • Proficiency with Microsoft Outlook, Excel, PowerPoint
  • Have a sound understanding of GMPs and various types of training documentation (e.g. SOPs, User Guides, OJTs, training curricula)


PHYSICAL/MENTAL REQUIREMENTS
  • Must be able to be aseptic gown qualified
  • Ability to gown to enter non-aseptic and aseptic areas of the LDM.
  • Collaborative skills and effective partnering skills in complex working environments
  • Ability to work independently and multi-task in a fast, priority environment
  • Meet eye exam criteria for visual inspection
  • Must be able to lift 50lbs


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Minimal travel required
  • Able to support 2nd Operations hours (1pm-9:30pm) as required
  • Ability to travel up to 5% to other sites, conferences and other events would be normal and expected.


Other Job Details:
  • Last Date to Apply for Job: December 8th, 2021


Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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.

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