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, your contribution will directly impact patients.
What You Will Achieve
You will be responsible for executing validation and qualification activities for computer systems used in quality control laboratories located across multiple sites in the Pfizer network. Your methodological approach will help us ensure compliance of our computer systems with company standards and government regulatory requirements. Your problem-solving ability will help us troubleshoot validation problems for software and assist laboratory staff on the bench. Your documentation skills will guide the creation, review and approval of validation process documents and technical reports related to complex software used to test important Pfizer products.
As an associate, your focus on the job will be achieving project tasks and goals. Through your knowledge and commitment, you will participate in a collaborative team environment to achieve these goals. It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Work effectively as a member of the Scientific and Laboratory Services (SLS) division of Pfizer Global Supply Quality Operations (QO).
- Adhere to all company and current Good Manufacturing Practices (GMP) procedures, as well as all safety regulations.
- Contribute to the completion of complex validation projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Assist with development and execution of validation protocols and documentation.
- Perform regular administration and maintenance activities of validated computer applications, including but not limited to, periodic review of audit trails and development of master data.
- Define problems, collect data, establish facts, and draw valid conclusion. Participate in deviation investigations to identify root causes and define corrective and/or preventative actions related to computer software.
- Assist laboratory staff with troubleshooting of computer system related issues in a collaborative and professional manner.
- Work in a team environment to meet all team objectives and communicate progress on scheduled projects.
Qualifications
Must-Have
- Applicant must have High School Diploma (or Equivalent) with six years of relevant experience in computer science; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience.
- Excellent attention to detail and familiarity with current Good Manufacturing Principles and/or Food and Drug Administration Regulations/Guidance.
- Adept at learning new software and technology quickly.
- Strong organization and communication with written and verbal skills and demonstrated ability to work effectively in a cross-site support model with colleagues of diverse backgrounds.
- Ability to work independently with limited oversight, complete work within agreed upon timelines and to a high-quality standard.
- Strong working knowledge of Windows Operating Systems and Microsoft Office, especially Outlook, Word, Excel and Teams.
Nice-to-Have
- Experience with laboratory computer application validation is desirable.
- Familiarity with a range of computer systems in a laboratory or other GMP setting.
- Understanding of FDA regulation 21 CFR Part 11 and electronic record/electronic signature expectations.
- Knowledge of information technology and network infrastructure.
- Working knowledge of equipment qualification and calibration specifically for laboratory equipment.
PHYSICAL/MENTAL REQUIREMENTS
This is a computer intensive job and may require long periods of sitting or repetitive tasks.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Minimal travel to supported sites as needed, <5%.
- Position is primarily remote but ability to commute as needed to one of following locations: Parsippany, NJ, Groton, CT, Lake Forest, IL or Kalamazoo, MI.
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Other Job Details:
- Last Date to Apply for Job: September 15, 2022
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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