This job has expired

Validation Chemist II

Employer
Pfizer
Location
McPherson, Kansas
Salary
Competitive
Closing date
Dec 15, 2022

View more

Discipline
Life Sciences, Analytical Chemistry
Position Type
Full Time
Organization Type
Pharma
You need to sign in or create an account to save a job.
Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the quality, discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

As part of the Quality Validation team, you are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations. You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe

How You Will Achieve It

  • Accountable for activities involved in analyzing chemical, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program, and includes environmental/utility monitoring and testing, analytical testing, microbial identification & testing, sterility testing, the installation, operation, and performance qualification of unique QC instruments, sample management, retains management, interpretation and evaluation of analyses in terms of accuracy and precision compared against established specifications. One may also be involved in establishing requirements for the transfer of methodology from R&D and method development.

    Perform standard qualitative and quantitative analysis on: processed validation, purchased raw materials, in-process products, pure drug substances, finished pharmaceutical preparations, stability samples, and contract manufacturing samples utilizing accepted gravimetric and spectrophotometric procedures, in accordance with approved testing procedures Pfizer, the National Formulary (NF), and various Pharmacopeia.
  • Utilizes standard analytical chemistry techniques. A working knowledge of HPLC analysis.
  • Prepare and standardize volumetric solutions, test solutions and reagents used in USP, NF and Pfizer monograph analysis.
  • Review completed data for accuracy before forwarding data to QA filing in the batch record.
  • Participate in employee involvement team(s).
  • Any other duties as assigned by supervisor.
  • Performs work in a structured environment under direction from supervisor
  • Communicate straightforward information, asks questions and checks for understanding
  • Perform Quality Assurance analytical testing in the chemistry laboratory.
  • Manage own time, professional development and be accountable for own results.
  • Prioritize own workflow, allocate work to others and assist in establishing their priorities.
  • Providing input for performance assessment of team members.
  • Perform standard chemical tests for conformance to company and compendial specification.
  • Maintain records of all analysis information of assigned products on data sheets for permanent file and proper entry of information on laboratory forms or data systems.
  • Evaluate all data obtained from analysis, identify discrepancy or deviation, consult with Supervisor
  • Perform standard qualitative and quantitative analysis on purchased raw materials, in-process products, pure drug substances, finished pharmaceutical preparations, stability samples, process validation samples, and contract manufacturing samples utilizing accepted procedures.
  • Interpret and apply compendial methodologies
  • Generate forms, labels, and other materials needed for formulation preparations as required.
  • Draft testing protocol and reports for method validations and experiments.
  • Ensures instruments are calibrated within specifications and function properly in accordance to Standard Operating Procedures.
  • Review completed data for accuracy.


Qualifications

Competent and understanding of fundamental principles of one or more technical or specialized body of knowledge. A bachelor's degree in a scientific field is required with not less than 2 years of experience in a laboratory setting. Perform repetitive or routine duties working from set instructions and under standard procedures. Make decisions that require choosing between limited options to resolve problems. Available for some off-shift work (2nd, 3rd,& weekend shifts) will be required

Must-Have

  • Bachelor's degree in Chemistry, or closely related scientific field, with a minimum of 2+ years of experience related to basic chemistry, Organic chemistry, and/or analytical chemistry (may be Quantitative Analysis or Instrumental Analysis related class).
  • Working knowledge of good laboratory procedures including safety practices is.
  • Must be proficient in the instrumental methods of analysis with preference on automated equipment. A minimum of two years of analytical experience in a pharmaceutical industry laboratory or equivalent preferred.
  • Ability to understand and carry out assigned duties with minimum supervision
  • Ability to make decisions independently and see projects from planning to completion


Nice-to-Have

  • Direct experience as a trainer
  • Working Knowledge of Waters Empower Software


PHYSICAL/MENTAL REQUIREMENTS

Considerable mental/visual concentration, coordinating manual dexterity with mental/visual attention - including alternating sitting/standing to perform tasks and strict documentation requirements.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Available for some off-shift work (2nd, 3rd,& weekend shifts) will be required. Minimal travel is needed.

Work Location Assignment:On Premise

*Job Details:

• Last Date to Apply for Job: December 14, 2022

• Eligible for Employee Referral Bonus: Yes

• Schedule: First Shift

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Research and Development

#LI-PFE
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert