Computer Systems Review Analyst

Power for Purpose
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 this position, you will be joining our Quality Control department. The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with computer system review, data restoration, and account recertification.
• This position requires the demonstrated capability to lead/provide strategic direction to effectively document periodic activities (for example, audit trail reviews) by minimizing rework, tracking quarterly progress and delivery as part of the overall execution plan.
• Key responsibilities are performing computer system metadata reviews and assessments of validation projects and then leading/managing the resulting remediation activities (for example, SOP update). This includes implementing DI control strategies (both technical and procedural controls) in the lab and influencing the DI/Compliance culture across the QC Organization.
• Additional responsibilities include providing support during board of heath audits and internal audits related to both the QC data management program and to all Quality Lab Data Systems.
• Also, must create, own and maintain QC metadata review standard operating protocols (e.g. audit trail evaluation, account recertification, and audit trail review).
• Additionally, performing periodic process improvements to innovate and simplify the roles workstream.

How You Will Achieve It

• Acting safely, knows and follows all EH&S safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely.
• Recognized as a Computer System Review Subject Matter Expert by supporting audits, inspections and investigations, reviewing/approving technical content to ensure compliance to regulations and Pfizer policy and standards.
• Recognized as a 'go-to" person for computer system review and having extensive technical knowledge of lab data systems and the related instrumentation used within QC.
• Independent thinker with strong organizational skills, thinking from both a tactical and strategic basis for site-based projects or global programs (i.e. DI global initiatives, and/or global interfaces).
• Demonstrated process understanding to drive troubleshooting and optimization using automation tools and system technology.
• Collaborate with site and off-site Digital colleagues to troubleshoot issues and to develop and deliver innovative solutions, best practices, and technical guidelines.
• Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines.
• Ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve or independently resolves complex issues.
• Applies discipline's principles, appropriate procedures, and leadership skills to develop action plans and contributes to executing toward individual, team, and project goals.
• Expertly solving highly complex problems and solving situation dependent multifaceted problems using even only ambiguous information.
• Receives feedback well from management and other colleagues, grows self utilizing feedback and takes accountability for actions and personal development.
• Collaborate/independently engage with a wide range of co-workers, customers and management within the Network to gather the input and background knowledge needed to complete assignments.
• Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail oriented behavior.
• Good judgment and correct decision making based on expert knowledge of Pfizer procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations.
• Decision making that includes impact awareness on future quality and compliance as well as impact on own work group, department, and site.
• Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, team, department, or Network goal/deliverable is off schedule.
• Delivery on large and complex high business impact projects/activities/changes.
• Able to identify and seek out external resources to build or enhance understanding of Computer System Review; supports training of staff; mentoring and coaching junior colleagues.
• Displays strong investigative or technological orientation with independence for design of projects and able to make significant independent contributions to the implementation new systems.
• Uses other Pfizer Divisions information to obtain new ideas and/or benchmarking against when replicating best practices or new processes.
• Contributes to site and Network Quality Operation related strategies and decisions Individual should have knowledge of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; analytical chemistry and/or Microbiology techniques and instrumentation, Empower experience, Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; Lean Labs; project management tools including stakeholder management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelor's degree with at least 2 years of experience, OR Master's degree with 0 years of experience, OR Associate's degree with 6 years of experience, OR High School Diploma (or Equivalent) and 8 years of relevant experience
• Experience in FDA regulated industry required
• Knowledge of laboratory analytical computerized systems validation and qualification.
• Excellent project management skills.
• Experience driving critical projects to completion within agreed upon timelines.
• Excellent oral, written and interpersonal communication skills.

Other job details

• Last day to apply: Feb 18th, 2025
• No Relocation Support available
• Employee Referral Bonus eligible
• Work Location Assignment: On Premise

Work Location Assignment: On Premise
The annual base salary for this position ranges from $80,300.00 to $133,900.00. 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. This position requires permanent work authorization in the United States.
Quality Assurance and Control
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