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Associate, Documentation Specialist

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Closing date
Feb 1, 2022

View more

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.

The Andover Liquid Dosage Manufacturing (AN-LDM) is located on the Pfizer Andover, MA campus and is responsible for the cGMP manufacture of phase I/II clinical drug product supporting the Pfizer Biotherapeutics portfolio.

What You Will Achieve

The Documentation Specialist is responsible for supporting AN-LDM Operations with GMP documentation support. This includes authoring manufacturing batch records (paper and electronic version), SOPs and other GMP documentations as required. The candidate will also assist with review of executed batch records, managing the lifecycle of all relevant GMP documentation (SOPs, logbooks, etc.), logging LIMS sample labels and Lot number creation within the current approved inventory system (CAIS).

How You Will Achieve It

  • Manage own time, professional development, prioritize workflows and be accountable for own results
  • Responsible for writing, revising, and issuing of drug product batch records for use by manufacturing technicians
  • Perform batch order creation and register the finished Drug Product as required into the inventory system Axis360
  • Execute batch records steps for label creation and logging GMP samples in the Labware LIMS system
  • Responsible for review and comment resolution of the executed manufacturing batch records for the AN-LDM operation team
  • Assist with ordering, receiving, maintaining, and archiving logbooks and other GMP documentation
  • Revise/improve clarity of standard operating procedures by incorporating Pfizer Human Performance (PHP) principles.
  • Maintains and communicates metrics for batch record review, conducts analysis to identify trends, makes suggestions for continuous improvement.


Qualifications

Must-Have

  • B.S./Associates Degree or HS Diploma, with 2-3+ years of relevant experience in a GMP document management/records management and or a combination of experience in production or scientific operations of biological therapeutics.
  • Previous understanding and experience working with various aspects of GMP manufacturing
  • Strong attention to detail, along with excellent communication and collaboration skills
  • Strong Computer skills in Microsoft Office required, e.g. MS Word, etc.
  • Excellent written and oral communication skills, and interpersonal skills to effectively communicate at multiple levels in the organization.
  • Able to identify opportunities for continuous improvements and enable implementation


Nice-to-Have

  • 5+ years in regulated pharmaceutical industry
  • BS in a technical or science field
  • Additional education/certification in electronic batch record systems and proficiency in Microsoft applications.
  • Requires thorough knowledge of cGMP and an ability to handle multiple projects


PHYSICAL/MENTAL REQUIREMENTS
  • Collaborative skills and effective partnering skills in complex working environments
  • Ability to work in a dynamic multi-discipline organizational model
  • Ability to work independently and multi-task in a fast, priority environment
  • Ability to understand technical documentation relevant to tech transfer


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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