Operations Specialist

2 weeks ago

Middleton, 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

In your role, you have the all-important task of preparation and review of required documentation, such as Good Manufacturing Practices, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) manuals. Supports production, business, and other processes in a team-based manufacturing environment. Performs activities in a variety of cross-functional areas including support of: production planning and control, total quality management, systems, manufacturing, equipment and facilities engineering, material management, and process reengineering. Your organizing skills will help you implement related documentation systems, propose change control processes and coordinate the review of procedures and forms. You will also provide input on quality control procedures and R&D documentation.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your focus and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

  • Own the API CI process including: Leading the CI meeting, Updating the CI board, prioritizing and coordinating CI projects and JDIs

  • Analyze data from data collection systems as a key input to the CI meetings (e.g. Pareto analysis)

  • Execute the tasks to support the Operation or Site functions.

  • Perform tasks related to Batch Record issuance and manufacturing execution planning

  • Provides input to manufacturing planning

  • Conducts studies pertaining to cost control, cost reduction, inventory control, and production record systems. On the basis of these studies, develops and implements plans and programs for facility/equipment modifications and revisions to operating methods.

  • Work within the Quality system including usage of Pfizer Document Management System (DMS) to ensure quality and compliance.

  • Oversee Documentation Control and other key administration functions of the DMS repository including the establishment of new processes leveraging the new repository to meet regulatory requirements.

  • Coordinate with cross functional teams for documents issuance, retrieval and storage of Good Manufacturing Practices {also cGMP} documents.

  • Work with SAP to assist with batch record issuance, BOM, and production planning.

Qualifications

Must-Have

  • Applicant must have a High School Diploma (or Equivalent and 6 years of relevant experience OR an associates degree with 4 years experience OR a Bachelors degree with 0+ years of experience.

  • Demonstrated experience in Document Management and Control

  • Familiar with GMP Procedural and Protocol writing

  • Ability to gain insight into the diverse processes in the API manufacturing and apply this knowledge in the creation of simplified instructions and procedures.

  • Proficient in Microsoft software including Excel, Word, PowerPoint.

Nice-to-Have

  • Project Planning experience

  • Lean or Six Sigma experience

PHYSICAL/MENTAL REQUIREMENTS

  • Capable to aseptically gown

  • Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis.

  • Job duties involve occasional lifting (less than 35 lbs.), reaching, and sitting while working at computer terminal.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must be willing to work beyond the hours typically defined as a 'regular' workday, which may or may not include weekends and holidays

OTHER JOB DETAILS

Last Date to Apply for Job: September 24th, 2024

Eligible for Relocation Package: NO

The annual base salary for this position ranges from $64,600.00 to $107,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. 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 | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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. This position requires permanent work authorization in the United States.

Manufacturing

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