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Quality Control Sr Associate Scientist, Analytical Chemistry

Company

Pfizer

Address North Carolina, United States
Employment type FULL_TIME
Salary
Category Pharmaceutical Manufacturing
Expires 2023-09-04
Posted at 9 months ago
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


  • Responsible for knowing, understanding and acting in accordance with Pfizer’s values and our OWNIT culture
  • May initiate and develop project plans to ensure projects timely completion.
  • May serve on cross functional teams to facilitate communications between Quality Control and other departments.
  • Performs tasks associated with maintaining GMP compliant Quality Control and Stability laboratories.
  • Responsible for appropriate creation, review and approval of GMP documentation (test records, and as assigned validation protocols/reports, test methods, equipment records, etc.) and ensuring adherence to Pfizer standards, guidelines and values.
  • Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
  • Assessing existing situations and suggesting improvements to increase compliance and innovation.
  • Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance.
  • May perform data trending activities and assist with metrics reporting.
  • Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS result and participating in associated laboratory investigation, reporting instrument issues and assisting with troubleshooting, etc.)


Qualifications


Must-Have


  • Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associate’s degree with 4 years of experience OR a bachelor's with at least 1 year of experience.
  • Excellent effective written and verbal communication and interpersonal skills
  • Basic computer skills (data entry and attention to detail) in Microsoft
  • Understanding of laboratory practices and analytical testing and use of analytical equipment: i.e. UV-VIS, HPLC, UPLC, pH, appearance, osmolality, TOC and conductivity, and various other instruments.


Nice-to-Have


  • Experience in Quality Operations
  • Experience leading continuous improvement projects.
  • Degree in Science or related field.
  • Experience in biotech or pharmaceutical industry
  • Laboratory experience, including HPLC with Empower
  • Experience with Laboratory Information Management System (LIMS)


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 mathematical problems and perform complex data analysis.


Non-standard Work Schedule, Travel Or Environment Requirements


Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.


Limited travel for the position; no more than 10% traveling.


Other Job Details:


  • Last day to Apply: June 14th, 2023
  • Eligible for Relocation Assistance: NO
  • 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