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Associate Specialist QO

Employer
Pfizer
Location
Kalamazoo, Michigan
Start date
Aug 8, 2022

View more

Discipline
Clinical, Clinical Medicine
Required Education
Associate Degree
Position Type
Full time
Hotbed
Best Places to Work
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 AchieveThis posting is for a position within Supplier Quality on the Packaging Inspection team. The Supplier Quality team is a team whose responsibility is to ensure the acceptability of raw and packaging materials, and their suppliers, used in the manufacture of drug substances and drug products.How You Will Achieve It
  • Inspect incoming packaging materials including vials, bottles, stoppers, caps, labels, inserts, carton, etc. Contemporaneously document findings and enter results into LIMS.

  • Second check and release batches for use in production.
  • Participate in iMEX-relatedness activities including continuous improvement (CI) and daily T1 meetings. May act as safety, standard work, visual management, CI, or structured Gemba leader.
  • Identify defects and participate in associated investigations.
  • Participate in calls with vendors.
  • Interact with warehouse personnel to assure timely receipt of tailgate samples.
  • Participate in unit-level continuous improvement projects.
  • Take on unit community service projects such as calibration tracking, notebook filing, SOP revision (periodic review), etc.
  • Complete training and annual performance activities promptly.
Qualifications

Must-Have
  • Applicant must have six years of relevant experience, OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience.
  • Experience in the pharmaceutical industry
  • Experience in Quality administered systems
  • Sound knowledge of current Good Manufacturing Practices {part of GxP}
  • Ability to work in a team environment within own team and interdepartmental teams
  • Effective written and oral communication skills
Nice-to-Have
  • Computer skills including experience with gLIMS, QTS, and SAP are desired. Experience using AMEX lab tools is desired.


PHYSICAL/MENTAL REQUIREMENTS

Physical Demands: Time split between office work, material inspection, and warehouse environments. Standing, walking, lifting, and moving containers up to 25 kg. Repetitive movements handling different packaging components are involved. Weekend and holiday work may be required.

Vision Requirements: Must successfully pass an eye exam. The position requires 20/20 vision with or without corrective lenses.

NON-STANDARD WORK SCHEDULE, TRAVEL, OR ENVIRONMENT REQUIREMENTS

N/A


Relocation support available

Work Location Assignment:On-Premise

Last date to apply - 8/26/2022

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

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