Pfizer Sr QO Specialist in Kalamazoo, Michigan
This posting is for a QO Tech Transfer Professional within PGS-Kalamazoo Quality Operations (QO). The team supports technical project implementation in Kalamazoo, providing the project team with a Single Point of Contact (SPOC) for QO support and system implementation. Projects include plant network strategy transfers, new product implementation in Codevelopment with Research & Development, and internal Continuous Improvement and Organic Growth.
Familiarity with GMP requirements and industry quality assurance practices and systems. With guidance, coordinate and implement the quality systems integration of a variety of projects, which includes working in the following areas of QO:
Analytical Method Transfer Exercise (AMTE) Support -- Coordinates bringing new analytical methods into the release labs to support the introduction of new products to the site, with a focus on:
1) Analytical technology capability assessments
2) AMTE protocol and report authoring
3) Test Plan creation
CMC-Site Compliance - Preparing the site regulatory submission strategy with key objectives related to:
1) Regulatory strategy development
2) Interaction with health authorities including preparation of PAI activities
3) Process Change Proposal/Request (PCP/PCR) authoring to support new product submissions
4) Maintain knowledge of product filing to support inquiry responses from internal and external customers
5) Participates in internal GMP audits and supports customer and regulatory audits, as needed.
QA Floor Support - Integrates new products in the site quality systems. Conducts and reviews non-conformance investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other cGMP functions. Provides guidance and oversight in identifying root cause and preventative corrective action. Leads and reviews formal risk assessments. Releases materials related to project activities. Activities include:
1) Strategy development and implementation
2) Lot Release
3) Deviation management
4) Change Control Management
QA Validation Support- Reviews and may help develop product and process validation strategies. Work with the project team to assure global validation strategies are executed with respect to:
1) Process Validation
2) Equipment Validation
3) Cleaning validation
Raw / packaging material Support - Supports the data gathering, evaluation and release of raw materials, packaging, and Pfizer produced products that conform to corporate, customer, and regulatory standards, with an emphasis on:
1) New raw material assessment
2) Test plan maintenance
2) Lot Release
This position is part of a career path/progression that includes three levels of opportunity - grade 4, 7 and 10.
Must have at least a bachelor degree in a science and at least 5 years of experience in pharmaceutical quality operations, including experience with Quality systems support in more than two areas of the following: Analytical testing, method transfer, deviation investigation, raw and packaging materials, manufacturing support, process validation, site compliance and project management related to active pharmaceutical ingredients, liquid / semi solids and/or injectable products.
Must use the Pfizer leader behaviors in day to day interactions and have good people skills, in addition to proven written and oral communication skills.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position may require occasional travel, dependent on project needs.
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.
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.
Last Date to Apply for Job: 6/28/18
Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.