ROLE SUMMARY
Consistently performs routine and complex analytical chemistry activities with a degree of independence. Demonstrates technical expertise in one or more analytical areas.
Performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, inprocess samples, finished product, process & cleaning validation samples, package samples and components as well as some specialized techniques.
Assays are performed in compliance with USP, FDA and other regulatory body requirements, Pfizer standard operating procedures, and approved license requirements. In addition, the individual writes, reviews and approves protocols, reports, and investigations associated with the laboratory and to support method validation activities.
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This position is responsible for providing time sensitive in-process testing in support of Operations as needed and with OBE 5 drug products.
Responsible for ensuring time-sensitive in-process lab testing is performed in support of Operations. This may require adjusting work hours as required or needed.
Compiles validation data into comprehensive reports. Work on analytical methods in support of new product launches and existing marketed products. Applies creative ability and specialized scientific knowledge to solving marketed product analytical problems or evaluating changes. Evaluates and implements new measurement technologies to improve sensitivity, selectivity, and/or the ability to characterize, excipients, in-process materials, and finished products.
Participate in Laboratory investigations, create Change Control, revise test methods, write protocol and perform approvals.
The position is accountable for ensuring that analytical measurements are accurate and that methods are in compliance with FDA and/or other applicable regulatory agency guidelines, cGMP, and corporate requirements.
ROLE RESPONSIBILITIES
Conducts assays
In addition to high technical competence, the colleague understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development.
Analyzes results
Analyzes and interprets project/study/investigation/review results independently. May utilize Laboratory Information Management Systems (LIMS). Develops problem solving skills. Makes tactical decisions independently based on the results.
Trains & Mentors
Trains analysts in new and existing procedures, techniques and governmental regulations as directed by management. Takes initiative; seeks out additional assignments, etc.
Lab Support
Responsible for planning and execution of all tasks needed to achieve routine goals. Seeks advice on planning from management when there are priority conflicts. Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner. May assist in coordinating the testing activities of the group.
SOPs and Admin
Able to make independent contributions to the development of new technologies developing and revising methods and procedures to assure compliance with applicable regulations; carries out technical and administrative duties as assigned.
QUALIFICATIONS
A minimum of a BS/BA in Chemistry or Biochemistry or Advanced degree preferred.
This position requires 5 years experience within Quality Control or other relevant analytical experience in the pharmaceutical industry. General lab equipment. Equipment troubleshooting.
Candidates will have prior experience in most, if not all, of the following:
- Making sound and effective decisions under pressure
- Working with other manufacturing sites to understand a broader perspective
- Exposure to Regulatory inspections includingdirect interactions
- Ability to effectively work within Quality Control, and across network channels, to accomplish goals
Knowledge of the following areas are critical for success in the role:
- ICH and other applicable industry standards
- Understanding the principles of Data Integrity
PHYSICAL/MENTAL REQUIREMENTS
ability to perform mathematical calculations
ability to perform complex data analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Responsible for ensuring time-sensitive in-process lab testing is performed in support of Operations. This may require adjusting work hours as required or needed.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $74 900,00 to $124 800,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7,5% 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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