Quality Systems Senior Analyst
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
You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients. Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of technology/methodology from R&D.
As a Senior Scientist, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be recognized as a technical expert and a scientific contributor. With your deep knowledge of the discipline, you will be an active team member whose decisions impact the project. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will be forecasting and planning resource requirements for your project team. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide team members.
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
Apply technical and functional knowledge to design experiments and independently complete work within own work group/ project team, working on multiple sub-projects in parallel.
Act as a technical and scientific resource within own project team/ discipline.
Perform tasks associated with maintaining and improving cGMP (current Good Manufacturing Practices) compliant Quality Control and/or Stability laboratories.
Apply discipline’s principles, appropriate procedures and leadership skills to develop action plans and contributes to executing toward individual, team and project goals.
Perform testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability.
Train junior colleagues and develop training plans and/or oversee training activities for groups.
Support audits and review/approve technical content ensuring both scientific merit and compliance to regulatory agency regulations and Pfizer policy and standards.
Design and create protocols related to compliant test method transfer and validation.
Organize reports and records related to equipment qualification/computer validation.
Assist with protocol non-conformance evaluations.
Identify and seek out external resources (e.g. Parenteral Drug Association, International Society for Pharmaceutical Engineering) to build or enhance understanding of scientific discipline.
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.
Assess existing situations and suggest continuous improvements to increase compliance and innovation.
Qualifications
Must-Have
Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
Excellent knowledge and handling of current MS Office Applications.
Excellent effective written and verbal communication and interpersonal skills.
Good knowledge of US, EU and ROW cGMP & GLP.
LabWare Master Data experience required
Nice-to-Have
Doctorate degree (PhD, PharmD)
Familiarity with Lean Six Sigma concepts, Lean Labs.
Familiarity with project management tools including stakeholder management.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Typically, a standard Monday through Friday, 1st shift.
May require support for site as needed beyond core business hours.
Work Location Assignment: On Premise
OTHER JOB DETAILS
- Last Date to Apply for Job: August 12, 2024
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: NO
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.
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.
