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QO Technical Associate III (3rd Shift)

Employer
Pfizer
Location
Kalamazoo, Michigan
Start date
Aug 31, 2022
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Job Details

*** Pfizer now offering $4,000.00 SIGN ON BONUS for successful hires through December 31, 2022***

“Schedule is subject to change”

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.

Using standardized procedures, the candidate will conduct a variety of microbiological environmental sampling in aseptic processing areas. The sampling performed supports high through-put pharmaceutical manufacturing.

In addition to performance of routine environmental sampling, the candidate will assist in the overall operation of the microbiology laboratory including:

  • Incubation of samples

  • Read out of sample results and entry of results into an electronic database

  • Completion of training activities

  • Maintenance of records, equipment, basic lab supplies, and reagents in accordance with current good manufacturing requirements.

  • Second checks records and assists in training others.

  • May represent work group within department teams

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.
  • Primary responsibility is to perform environmental sampling in aseptic processing area.
  • This will include setting up sampling materials and data summaries in a computerized database, incubating samples, and interpreting and documenting results.
  • Recognizes atypical data and informs supervision of relevant problems.
  • Enters, reviews, and approves data in computerized database.
  • Will second-check the work of others.
  • Transports samples and supplies between the laboratory and production environments.
  • Applies technical knowledge of microbiological principles, theories, concepts and Pfizer processes and industry practices/standards to their daily work.
  • Is able to work both independently and as part of a team.
  • May perform assays on purchased materials, investigative samples, and in-process samples in a laboratory service operation so that the unit and organizational objectives are met.
  • Performs equipment & laboratory maintenance.
  • Orders and maintains laboratory supplies.
  • Operates within established HR policies and basic colleague relations guidelines.
  • Contributes to the completion of specific team objectives and assigned project milestones.
  • May initiate investigations/ Assist in Preventative and Corrective Actions.
  • Job Task Trainer
  • Routes GCR documents for approval in electronic database.
  • Enters, reviews, and approves data in computerized database. May have administrator rights in environmental monitoring database to assist with error correction and troubleshooting.

Qualifications

Must-Have

  • High school diploma (or equivalent) plus 4 years of relevant experience; in a laboratory, QA role, or manufacturing environment; or Associates Degree and 3 years of experience of relevant experience; in a laboratory, QA role, or manufacturing environment, or Bachelor’s Degree in biological sciences plus 1 year of experience required.
  • Good oral, written and interpersonal communication skills within a diverse team setting are required.
  • Basic math skills and computer skills such as data entry, along with a high level of attention to detail are required.
  • The successful candidate will possess a demonstrated ability to organize time independently, be able to perform several tasks concurrently (ability to multi-task), and be able to meet objectives in a flexible, team-oriented environment.
  • Preferred candidate will have previous laboratory experience, including a basic understanding of microbiology and aseptic technique, and/or previous experience in an aseptic/ classified manufacturing environment, and/ or previous experience in a manufacturing, and/ or customer focused role.

Nice-to-Have

  • Bachelor's Degree
  • Quality Control experience in a pharmaceutical industry
  • Experience in a GMP environment


PHYSICAL/MENTAL REQUIREMENTS

  • Must be capable of maintaining aseptic gowning qualification in a production environment.
  • Must be capable of manual manipulations with fine dexterity.
  • Must be capable of walking for extended periods, bending, reaching and lifting (less than 35 lbs.) during routine job activities.
  • Extended time working at a computer terminal is also required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Must be capable of maintaining aseptic gowning qualification in a production environment.
  • This is a 3rd Shift position (10:00PM – 06:30AM) Monday – Friday ( Start of week begins on Sunday night).
  • Weekend, Holiday, and Overtime hours will be required in order to meet business and/or customer needs.
  • Work Location Assignment:On Premise

Other Job Details

  • Last Date to Apply for Job: November 13, 2022
  • Eligible for Relocation Package: NO

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.

Quality Assurance and Control

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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