Quality Technician

Employer
Pfizer
Location
Pleasant Prairie, Wisconsin
Posted
Sep 17, 2021
Ref
4824575
Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time

Role Summary

Provides Quality support to the Pleasant Prairie Logistics Center’s (PPLC) warehouse operations.  Supports the implementation, performance and monitoring of GMP/GDP Quality Systems and compliance related initiatives within the PPLC including documentation management, investigations, change control, commitment tracking and internal audits.

Role Responsibilities

Partners with the rest of the PPLC Quality team to support PPLC Operations and drive continuous improvement efforts.

Executes the appropriate actions to support control of material statuses within the distribution network. This includes:

  • Reviewing and managing all documentation for inbound receipts and release product into distribution;
  • Evaluating in-transit temperature data to identify excursions that may have occurred and provide disposition directives;
  • Reviewing receiving documentation for imported products and release products off FDA/Customs Hold as appropriate;
  • Evaluating inbound receipt criteria to support timely release of finished goods into available inventory;
  • Approving documentation for products being shipped to the PPLC under quarantine and ensure material status is accurate;
  • Process Quarantine Alert Notices (QANs) received by verifying or executing batch restrictions and Global Batch Hold transactions in SAP;
  • Evaluate product returns, provide disposition instructions and execute the transactions in SAP.

Interface with other departments to manage/facilitate inventory receipt and release movements and control material status within the PPLC.

Manage communications, notifications and alerts to manufacturing and quality locations worldwide.

Performs a critical role in championing quality/compliance systems, facilities, equipment, processes, and culture.

Provides Subject Matter expertise on Quality/Compliance related matters to the LCs.

Assists GMP related investigations and conduct quality portion of the investigations as appropriate. 

Assist in development, tracking, and analysis of quality metric data.

Responsible for performing other activities and special projects as assigned to ensure quality, compliance and continuous improvement.

Qualifications

Must-Have

  • High School Diploma or GED
  • Previous experience in a warehouse or quality operation
  • Experience in Ultra Low Temperature Storage, Packaging, and Logistics
  • Certification in assigned area, if applicable
  • Experience in a Good Manufacturing Practices {also cGMP} environment.
  • Ability to handle multiple tasks concurrently and in a timely fashion
  • Must be self-motivated and work with minimal direction
  • Demonstrates engagement in helping to achieve warehouse, team, and individual goals

Nice-to-Have

  • Associate's or Bachelor's Degree
  • Experience in parenteral drug product pharmaceutical warehousing
  • Demonstrate proficiency in computerized systems
  

PHYSICAL/MENTAL REQUIREMENTS

Must be able to lift up to 30 lbs. on rare occasions.  General office-based activities, requiring sitting or standing and occasionally walking for extended periods of time. Very infrequent business travel.

Critical thinking skills, excellent writing skills, and good interpersonal communication skills are required.  Ability to adapt to constantly changing expectations, parallel objectives, and changing priorities.  Must be able to learn quickly, then apply those learnings to the role.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

1st shift but some potential for off-shift or weekend work, very infrequent business travel

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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