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Documentation Specialist
4 months ago
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
The Documentation Specialist 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.
The Documentation Specialist will support the operations team by managing the lifecycle of controlled documents, including Standard Operating Procedure (SOP) authoring, processing, routing, and periodic review. Additionally, you will be the central person for batch record issuance/review and will act as a liaison for comment resolution between the operations and quality assurance teams.
Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues. It is your focus and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Work within the Quality system including usage of Pfizer Document Management System (DMS) to ensure quality and compliance.
Review, edit, and format master documents (e.g. Manufacturing SOPs, solution records, and
batch records) according to approved procedures and templates
Assists with document changes related to CAPAs and change control system (Trackwise,
eQMS)
Work in a collaborative environment of a multi-disciplinary project team
Drive comment resolution of paper and electronic batch records
Keep metrics for batch record review, look for trends, and communicate those metrics to
management when needed
Coordinate with cross functional teams for documents issuance, retrieval and storage of Good Manufacturing Practices {also cGMP} documents.
Qualifications
Must-Have
Associates with no experience OR High School 4 to 6 years of experience
Experience with authoring SOPs in an electronic document management system
Prior experience in a GMP manufacturing setting
Experience with reviewing manufacturing batch records
Nice-to-Have
Project Planning experience
Experience using a quality management system, such as Trackwise or Veeva, to initiate and track CAPAs
Excellent written and verbal communication skills
Strong computer skills in Microsoft Office (e.g. MS Word, MS Excel)
Prior experience in a quality assurance role
Work Location Assignment:On Premise
The annual base salary for this position ranges from $64,600.00 to $107, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
Quality Assurance and Control
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