QC Scientist, Stability at Pfizer in Sanford, North Carolina

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 methodology from R&D.

 

As a Scientist, your deep knowledge in the discipline, will make you an active team member who influences at the project team level. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.

 

It is your knowledge and skills that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

 

How You Will Achieve It

 

• Contribute to achievement of goals at the work group/ project team level as a full team participant.
• Perform tasks associated with maintaining {Current} Good Manufacturing Practices {part of GxP} compliant Quality Control and Stability laboratories.
• Represent Quality Control Analytical in cross functional and site product meetings.
• Interpret data and make recommendations and reach decisions based on data and management input.
• Apply existing techniques and procedures, with recommendations, and implementation of modifications for improved efficiency, or devise and develop new microbiological Reporting issues to management and participating in issue resolution.
• Train junior colleagues, develop training plans and oversee training activities for groups.
• Provide subject matter expertise for standard operating procedures and quality standards content, as well as providing gap analysis to ensure that the environmental monitoring program is compliant with all regulatory requirements.
• Support change controls, investigations and other technical documents.
• Participate in regulatory filing writing in sections related to analytical method and stability testing.
• Determine environmental monitoring locations and qualification requirements for aseptic facility modifications and new facilities.
• Conduct and review non-conformance investigations related to aseptic manufacturing.
• Review and approval of environmental monitoring data and approval of data in Laboratory Information Management System for lot release.

 

Qualifications

 

Must Have:

 

• Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.

 

Individual should have k nowledge of:

 

• US, EU, and ROW cG x P ; ICH guidelines; analytical chemistry and/or Microbiology techniques
• Laboratory Information Management System ( LIMS ) ; Global Quality Tracking System ( TrackWise TM application ) ;
• Microsoft Office™ applications specifically Word, Excel , and PowerPoint;
• Lean S ix Sigma concepts ; project management ; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments .
• Responsible for knowing, understanding and acting in accordance with Pfizer's values

 

PHYSICAL/MENTAL REQUIREMENTS

 

• Ability to lift 30 lbs , stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/ cabinets
• Intellectual capability to perform complex mathe matical problems and perform complex data analysis.

 

NON-STANDARD WORK SCHEDULE, TRAVEL, OR ENVIRONMENT REQUIREMENTS:

 

• This role is standard day Monday through Friday work shift; some off-shift support needed when issues arise.
• During current pandemic, work will be split between working in office and remote setting.

 

OTHER JOB DETAILS:

 

• Last day to Apply: November 22, 2024
• Eligible for Relocation Assistance: Yes
• Work Location Assignment: On Premise

 

The annual base salary for this position ranges from $78,000.00 to $130,000.00. 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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