Why Patients Need You

　　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

　　In your role, you have the all-important task of preparation and review of required documentation, such as Good Manufacturing Practices, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) manuals. You will be relied on to prepare procedure manuals, quality control manuals, engineering documents, manufacturing instructions and change authorizations in accordance with company policy and government regulations. Your skills will help you implement related documentation systems, propose change control processes and coordinate the review of procedures and forms. You will also provide input on quality control procedures and R&D documentation.

　　As a Team leader, you will be involved in managing work teams in a division, along with technical and financial resources of the team. You will coach your direct reports on day-to-day activities. and be relied on to solve complex problems within your area of expertise.

　　It is your dedication and hard work that will make it possible for customers and patients to receive the medicines they need, when they need them.

　　How You Will Achieve It

　　Manage multiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity.Support project objectives through document design/creation/revision, document review and training course development.Work with internal teams to design, create and implement documents (using human performance principles or other relevant tools) that are user friendly and compliant.Develop, maintain and ensure the site document management system including procedures, guidelines, templates, numbering, filing compliance to Pfizer Quality Standards (PQS) and ICH guidelines.Ensure documentations are updated to the latest version and issued to shop floor.Ensure control of changes / updates / proper filing/archival and easy retrieval in the document management system.Control issuance and reconciliation of critical GMP forms used by various departments on site and the use is meeting the data integrity requirements.Ensure the site document retention schedule align with the Pfizer guidelines and meeting the regulatory requirements.Provide cataloging of the existing archival system, allocate archival space and issue proper retention schedule label code for department owners, monitor and track the space of archival room.Arrange, manage and coordinate the physical destruction of documents with department owners and third-party contractors.Supervise and/or review outputs of colleagues, contractors or supporting staff, as required, for project support activities.

　　Qualifications

　　Must-Have

　　Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience ORAssociate's degree with 6 years of experience ORBachelor's degree with at least 3 years of experience ORMaster's with more than 1 year of experience.Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, Access and Paradox)Experience in Technical writing, creating electronic documentation and using electronic document management systems.

　　Nice-to-Have

　　People Management experience.Strong oral, written, communication, presentation and interpersonal skills.Experience in traditional and modern training methods (mentoring, coaching, on-the-job, in classroom training, e-learning, workshops, simulations etc.) preferred.Experience in developing high-quality training materials (including those with pictures, animations, videos and simulations).Experience using data analysis computer tools and statistical analysis is preferred.

　　Physical / Mental requirements

　　Occasionally lift a computer system and/or instrument up to 50 pounds.Use a computer terminal for up to 8 hours per shift, work around moving equipment.Stand for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective.

　　Non-standard work schedule, travel or environment requirements

　　Primary work schedule is Day shift, Monday - Friday but evenings, weekends and holidays will be required, as needed to support manufacturing processes at the Rocky Mount site.Must be able to wear proper gowning and PPE in laboratory and manufacturing areas as required to meet GMP and/or OSHA requirements.Minimal travel may be required.Work Location Assignment: On Premise.

　　Other job details

　　Last day to apply: November 8, 2023.

　　The annual base salary for this position ranges from $75,700.00 to $126,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% 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 | (uscandidates.mypfizerbenefits.com). 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.

　　Quality Assurance and Control

　　#LI-PFE