Quality Systems Senior Analyst

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

Supports the Pfizer Sanford, NC Quality Assurance department by performing Quality Operations Systems activities related to LIMS associated with clinical and commercial products, raw materials, validation, stability, and environmental monitoring.

How You Will Achieve It

Colleagues should demonstrate the following:

• Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) and Pfizer Quality Standards to be a key contributor
• Suggest improvements and participates in continuous improvement activities
• Can generate metrics to support continuous improvement of the site
• Responsible for prioritization and associated timely completion of activities/deliverables
• Identifies and takes remedial action or seeks advice when a personal or project goal/deliverable is off schedule
• Contribute to the interpretation of cGMPs for commercial and clinical product
• Plan and execute projects
• Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development
• Independently able to resolve issues and represents QO in cross-departmental/cross-site meetings
• Effective written and verbal communication and interpersonal skills
• Capability of understanding requirements of LIMS builds
• Capability of designing complex queries to retrieve LIMS master data
• Collaborates and independently engages with a wide range of co-workers, customers, and management within the OpU to gather the input and background knowledge needed to complete assignments
• Identifies issues and reports them to appropriate management attention immediately
• Ability to organize own work to meet project deadlines
• Support regulatory audits as needed
• Good judgment and correct decision making based on Pfizer procedures, PQSs, technical experience; and industry guidance/regulatory regulations
• Interface with and represents QO in cross-departmental and cross-site meetings, manage working area and projects/changes to accomplish change activities/project deliverables

Qualifications

Must-Have

• High School Diploma (or Equivalent) and 10 years of relevant experience OR an Associate's Degrees in Computer Science or technology based (preferred)

with 8 years of experience OR a Bachelor' s Degree in Computer Science or technology based (preferred) with at least 5 years of experience OR Master's Degree in Computer Science or technology based (preferred) with more than 3 years of experience, OR a PhD in Computer Science or technology based (preferred) with 0+ years of experience.

• Good knowledge of US, EU and ROW cGMP & GLP.
• Excellent knowledge and handling of current MS Office Applications.
• Experience required in LIMS, computer documentation or computer validation.
• Excellent effective written and verbal communication and interpersonal skills.
• Understanding of LabWare LIMS Master Data

Nice-to-Have

• Knowledge of Labstation Instrument Integration
• SQL
• LIMS BASIC

Other Job Details

• Last day to apply: August 29th, 2023
• Employee Referral Bonus eligible

Work Location Assignment: On Premise

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