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Environmental Monitoring Aseptic Tech 1

2 months ago

Mcpherson, United States Pfizer 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.

Role Responsibilities

  • Perform environmental monitoring tasks for the aseptic environment, other controlled areas, and plant utility systems following specified instructions and techniques from Standard Operating Procedures (SOP), Training Material, and other GMP documents.
  • Ensure all tasks are completed in a GMP compliant and safe manner.
  • Document all tasks within MODA, LIMS, or standard laboratory paper documentation utilizing GDP principles.
  • Entry of information into laboratory logbooks as applicable for tasks per SOP.
  • Partner and communicate with operations, aseptic services, validations, and other site departments as required for support of operations and GMP processes.
  • Perform Environmental Monitoring System (EMS) alarm acknowledgement.
  • Actively participate in daily and weekly laboratory meetings.
  • Accurately complete task management tools and handover communications.
  • Perform general lab tasks including cleaning and equipment preparation
  • Maintain training for all required tasks.

Qualifications

Must-Have

  • High School Diploma or GED
  • 0-2+ year's experience
  • Certification in assigned area, if applicable
  • Successful hands-on analytical testing experience in a Good Manufacturing Practices {also cGMP} environment
  • Technical Skills- Knowledge of laboratory equipment, testing and technique
  • Basic math skills and computer skills, such as data entry, along with a high level of attention to detail
  • Strong organizational skills and ability to multi-task across projects and activities
  • Must be self-motivated and work with minimal direction
  • Ability to read, communicate understanding and follow written procedures

Nice-to-Have

  • Bachelor's Degree
  • Demonstrate proficiency in computerized systems, such as Laboratory Information Management System and Mobile Data Acquisition (MODA)
  • Prior experience using laboratory equipment such as Active Air Samplers, Particle Counters and working in a clean room.

PHYSICAL/MENTAL REQUIREMENTS

  • Long Periods of standing and working in controlled environment gowning.
  • Ability to lift necessary equipment (less than 50 lbs), occasional reaching and bending may be required.
  • Ability to perform basic mathematical calculations, data analysis, and data entry. Extended time working on computers or tablets may be required.
  • Able to ability to achieve and maintain gowning qualifications as well as perform work in an aseptic environment.
  • Maintains a clean and organized environment

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Holidayweekend, and overtime hours may be required in order to meet business and/or customer needs; flexibility is required.
  • Overtime and weekend work will be required.
  • Rotating first shift 2/2/3 6AM to 6PM

Work Location Assignment: On Premise

The salary for this position ranges from $20.21 to $33.68 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. 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 ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States – Kansas – Mcpherson location.

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


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