Job description
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 part of the business support team, you are recognized as an advisor by colleagues in the group due to your comprehensive knowledge and skills in your area of expertise and understanding of the larger organization. You are innovative in identifying solutions to problems by taking a broader perspective that benefits the organization. You encourage collaboration and communication within the team and across groups to influence desired outcomes. You train others and provide guidance to the team that helps us achieve our goal of providing the best healthcare to our patients.
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
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Manage own time and professional development and allocate the work of others and assists in establishing their priorities.
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Serve as point person in key areas of administrative knowledge and execution.
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Route various documents in the Document Management System (DMS) and complete DMS reviews and approvals.
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Process documentation for effective dating through appropriate process flow as indicated by supervisor.
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Perform the creation, distribution, retrieval and storage functions related to production logbooks.
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Edit and write Standard Operating Procedures (SOPs) and other documentation as needed.
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Maintain Documentation department filing, review and approve documents in the change control system.
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Initiate and facilitate change requests in the Global Quality Tracking System (QTS) and other systems.
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Reconcile change requests from initiation to closure.
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Ensure adherence to all plant safety rules in area of responsibility.
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Follow standard operating procedures (SOPs) and training course plans (TCPs), staying current with training requirements.
Qualifications
Must-Have
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High School Diploma or GED and 6+ years’ of experience.
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Excellent verbal and written communication skills and attention to detail.
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Demonstrated ability to work/contribute in a team-based environment.
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Proficient with Microsoft Office.
Nice-to-Have
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Bachelor’s Degree.
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Advanced computer skills.
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Ability to work independently and multi-task in a fast, priority switching environment while demonstrating a positive attitude.
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Strong reading, comprehension and proof reading skills, strong organizational skills.
PHYSICAL/MENTAL REQUIREMENTS
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 clothing as needed(lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Individual will be expected to work nonstandard schedule as needed to support the business objectives
OTHER JOB DETAILS
- Last Date to Apply for Job: January 26, 2023
- Eligible for Relocation Assistance: No
- Work Location Assignment: Flexible
Relocation assistance may be available based on business needs and/or eligibility.
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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