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Documentation and Training Coordinator

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Closing date
Jan 21, 2022

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Sector
Pharmaceutical
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
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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.

The Documentation and Training Coordinator is part of a multi-disciplinary team responsible for supporting cGMP production of phase I/II clinical drug substance within the Pfizer Andover Clinical Manufacturing Facility, located in Andover, MA.

What You Will Achieve

The Documentation and Training Coordinator will support the operations team by managing the lifecycle of controlled documents, including Standard Operating Procedures (SOPs) and Manufacturing Batch Record (MBR) authoring, processing, routing, issuance, reconciliation and archival.

Additionally, this position will also be responsible for coordinating training activities for non-operations specific activities (gowning, flow of personnel, flow of equipment, etc.), and acting as the facility Subject Matter Expert (SME) for training related initiatives.

How You Will Achieve It

  • Author and revise manufacturing documentation (e.g. SOPs) according to approved procedures and templates.
  • Assists with controlled document issuance, reconciliation, and archival.
  • Support internal and external regulatory inspections by providing documents from the global document management system.
  • Serve as Subject Matter Expert of the global document management system.
  • Acts as the facilities primary point of contact with the Quality Assurance Training group.
  • Lead and support training program optimization initiatives.
  • Administer instructor led and On-The-Job (OJT) training.
  • Management of paper training records.
  • Work in a collaborative environment of a multi-disciplinary project team.


Qualifications

Must-Have

  • Bachelor's degree and 3+ years in the Biotechnology or Pharmaceutical industries.
  • Experience in authoring SOPs or MBRs
  • Experience in delivering OJTs
  • Good working knowledge of regulatory compliance requirements in a cGMP environment.
  • Strong interpersonal, teamwork, and collaboration skills.
  • Strong workload planning skills, organization, attention to detail, and follow through.
  • Excellent written and verbal communication skills.
  • Ability to prioritize and multi-task concurrent project demands.
  • Strong computer skills in Microsoft Office (e.g. MS Word, MS Excel.)


Nice-to-Have

  • Strong history of documentation writing and implementation in a cGMP field.
  • Prior experience using Trackwise or similar system for change controls, CAPAs, and investigations.
  • Prior experience in developing and assigning training curricula for various roles


PHYSICAL/MENTAL REQUIREMENTS
  • Must be able to perform and demonstrate the gown/de-gown procedures necessary to access manufacturing spaces with various gowning requirements.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • This is a 1st shift position (8:00am - 4:30pm).
  • Ability to work in a clean room environment


Other Job Details:
  • Last Date to Apply for Job: February 2nd, 2022


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.

Research and Development
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