CQ Lab Analyst II – Incoming Materials – 2nd Shift

Employer
Pfizer
Location
Rocky Mount, North Carolina
Posted
Jun 20, 2022
Ref
4857274
Required Education
Associate Degree
Position Type
Full time
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

Your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Manage own time, professional development and accountable for own results.

  • Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.

  • Responsible for maintaining laboratory compliance.

  • Interpret and evaluate data in terms of accuracy, precision, trends, and potential Good Manufacturing Practices {also cGMP} impact and recommends appropriate corrective action where necessary.

  • Perform, document, record check, and troubleshoot qualitative or quantitative assays on samples using techniques that vary from use of standard laboratory equipment to highly modern and automated instrumentation.

  • Perform testing for semi-finished goods and finished goods testing, validation sample, and other testing in accordance with approved procedures and test methods, and record the test results in timely manner.

  • Investigate, analyze, problem solve, and communicate technical information to internal and external customers.

  • Ensure all reagents and reference standards are valid and stored according to requirement.

  • Comprehend and perform both routine and non-routine analyses from compendia and internal sources.

  • Work effectively in a fast-paced, customer-oriented, team laboratory environment to analyze final drug products in the Drug Product Laboratory.

  • Train and support less experienced analysts, working as a Certified Fellow Employee and mentor to aid in their development as analysts.

Qualifications

Must-Have
  • BS/MS in Chemistry or BS Science Degree.

  • 0 - 2 years analytical laboratory experience in a GMP regulated environment.

  • Certification in assigned area, if applicable

  • Incoming Materials experience preferred.

  • Willing to learn and develop a career in the pharmaceutical industry.

  • Capable to read, understand, and execute instructions in basic laboratory procedures.

  • Experience in parenteral drug product pharmaceutical manufacturing is plus but not required.

  • Successful hands-on analytical testing experience in a GMP environment is plus

  • Able to function independently, but asks questions as necessary

  • Accepts dynamic work sequences

  • Actively participates in daily and weekly planning discussions with his/her teammates and supervision (as needed) offering suggestions to improve Right First Time and schedule adherence as needed

  • Consistently communicates work sequence status to supervisor in a timely manner.

  • Where scheduled work was not achieved, actively participates in discussions to identify opportunities for correction and improvement.

  • Demonstrates engagement in helping to achieve CQ laboratory, team, and individual goals.

  • When faced with roadblocks and issues, routinely offers suggestions for improvements

  • Is a positive influence on the CQ laboratory, often going out of his/her way to support and assist teammates on the same shift wherever possible.

  • Has understanding of basic non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter, etc.

  • Has understanding of performing basic measurements on packaging materials using various instruments including optical comparators, Vernier calipers, gauges, etc.

Nice-to-Have
  • Demonstrate proficiency in computerized systems, such as Laboratory Information Management System

    ROLE SUMMARY

    This position is specific to Incoming Material testing. All applicants must be able to interpret commodity specification instructions while adhering to all local laboratory policies and SOPs. Applicants should be comfortable with dynamic work sequences and must be self-motivated and work with minimal direction.

    The CQ Lab Analyst II, will perform visual and dimensional analysis for incoming materials in a safe, compliant and efficient manner. The Job responsibilities include performing visual and dimensional testing to evaluate the quality of the incoming materials to demonstrate that the quality of our products meet the high standards of quality.

    Report testing results through computerized systems, or through standard laboratory paper-based documentation. Other related duties essential to these operations or special assignments as required.

    ROLE RESPONSIBILITIES

    • Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified.
    • Follows procedures at all times, adopting cGMP, cGDP practices.
    • Follows supervisor directions at all times.


    PHYSICAL/MENTAL REQUIREMENTS

    Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

    There are no out of the ordinary travel or shift requirements associated with the position.Individual will be expected to work nonstandard schedule as needed to support the business objectives


    Work Location Assignment:On Premise

    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.

    Quality Assurance and Control

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