Hiring company: Pfizer
ROLE SUMMARY
Independently performs routine and non-routine quality control testing of raw materials, in process, finished product, and stability samples within the framework of site policies, departmental procedures, and current Good Manufacturing Practices (cGMP) regulations. Is familiar with materials management, independently performing sampling and inspection and demonstrates the ability to recognize reject situations and handle them appropriately. Participates in investigations, team projects, and special project studies to accomplish company and departmental objectives. Records and reports data accurately and in compliance with current methods/Standard Operating Procedures (SOPs), United States Pharmacopeia (USP/NF), other compendia as applicable, and cGMP. Knowledge of HPLC, GC, Chromatography Data Software application, titrations, pH, Karl Fisher, and General Wet Chemistry/Compendial Testing. Performs additional duties under the guidance of laboratory management or designee.
ROLE RESPONSIBILITIES
The essential functions of this position may include, but are not limited to:
• Performs routine set up, calibration, operation, and maintenance of laboratory test instruments/equipment.
• Analyzes samples per established departmental/site/corporate policies, specifications, and procedures.
• Prepares solutions and standardizes test solutions as defined in analytical method or compendia.
• Performs assigned work in a timely and safe manner conforming to regulatory, company, and compendial requirements.
• Practices cGMP, which includes, but is not limited to, proper laboratory documentation and maintenance, archival of documentation/raw data, attention to specification limits for any tests performed, and immediate notification of any out-ofspecification (OOS) results.
• Documents/records analytical tests/data, ensuring reports are accurate and complete with documentation of procedures, equipment/instruments, and reagents used in analytical testing.
• Demonstrates practical laboratory skills, and a thorough knowledge of chemistry theories, analytical techniques, and quality procedures.
• Reviews and revises SOPs, analytical methods and related procedures/documents
• Samples API’s, Excipients, and Processing Aids upon arrival, at retest intervals, and for special requests for use in manufacturing.
• Performs inventory transactions for sampling/release/rejection of raw materials and support chemicals in PRISM.
• Files/helps maintain the Document Control Room.
BASIC QUALIFICATIONS
Knowledge of compendia; USP, EP, and others as applicable, cGMP guidelines, FDA regulations; laboratory safety procedures, laboratory instrumentation, and SDS; knowledge of inorganic and organic chemistry principals.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the minimum knowledge, skill, and/or ability necessary. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience: Bachelor Degree in Chemistry or related science field and up to 3 years of experience, or an equivalent combination of educations and experience/training; some laboratory experience in a GMP regulated environment is desirable.
Language Ability: Ability to read and understand applicable compendia methods, SOPs, general business periodicals, professional journals, technical procedures, and or governmental regulations; author scientific/technical reports, business correspondence and departmental procedures.
Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals; perform simple statistical functions and graph data.
Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions.
Computer Skills: To perform this job successfully, an individual should have knowledge of Windows based software applications such as Word, Excel, and Outlook; knowledge of chromatography data processing software, specifically Empower, is preferred/desirable.
Must have the ability to multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under and manage to strict production, time and performance deadlines. Must be willing and able to work beyond the hours typically defined as a “regular” workday, which mayor may not include weekends and holidays.
PHYSICAL/MENTAL REQUIREMENTS
While performing the duties of this job, the employee is occasionally exposed to wet or humid conditions (non-weather); work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; extreme cold (non-weather); extreme heat (non-weather) and risk of electrical shock. The noise level in the work environment is usually moderate. The employee is frequently required to stand; walk; use hands/arms to handle, or feel and reach; occasionally required to sit; stoop, kneel, crouch; must occasionally lift and/or move up to 75 pounds. Specific vision abilities required by this job include ability to adjust focus. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
The position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short, or long term basis. Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (“green card holders”), Refugees and Asylees.
Last date to apply for job: November 16, 2021
Eligible for Employee Referral Program
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.