11 days old

QO Specialist APRR

Kalamazoo, MI 49007
**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**

This position is for a QO Specialist on the Annual Product Record Review (APRR) team within the Product Review and Investigation unit in Quality Operations. The QO Specialist responsibilities will include using various computer systems to pull the data for and author a subset of approximately 200 APRR reports written for products manufactured at the Kalamazoo site. The process includes the compilation and review of release data, stability data, deviations, regulatory and site changes, and validation activities; and, the summarization of that data into a concise report that is reviewed by the QO product professional and approved by production and quality management. Record and analyze data for internal stability reports (ISR) and APRR's. Authoring of ISR's, APRR memos, and APRR Executive Summaries.

**How You Will Achieve It**

+ Prepare the APRR or internal stability report in accordance with established procedures

+ Query data from multiple systems to meet established due dates for items such as APRRs and ISRs. Systems used include, but are not limited to: LIMS, SAP, Batch Analysis, analytical reports, Cognos and Business Object reports, PDM and QTS. Numerous legacy systems are also queried for data.

+ Work with the applicable QO colleagues for the review and revision of the APRR or stability reports including entry into the electronic change control system

+ May be assigned additional responsibilities as required, including preparation of the APRR or stability schedules, updates to procedures, audit support and training of other team members.

+ Adhere to strict deadlines and assignments in order to meet site quality metrics of 100% on-time delivery of all APRRs or stability reports

+ Support external audits including interfacing with regulatory agencies, registrars, corporate and customers

+ Work in a team environment to meet all team objectives



+ Bachelor's degree in a scientific field (Chemistry, Biochemistry, or related science)

+ 2 years of technical writing experience in manufacturing or laboratory environment (review and reporting of data from computerized systems.)

+ Excellent organizational skills, and ability to handle changing deadlines. Must possess flexibility to respond to constantly changing conditions and priorities.

+ Good communication skills to deal with all levels of customers and partners, both internal and external

+ Demonstrated experience and skills in documentation of scientific or quality information.

+ Knowledge and understanding of GMP requirements and DP manufacturing processes and operations, with the ability to propose appropriate corrective actions

+ Demonstrated critical thinking, ability to pay close attention to detail and accuracy, and meet established due dates

+ Ability to follow written and verbal directions and properly handle confidential documents.

+ Demonstrated ability to work both independently and in a team environment.

+ Proficiency in IT systems such as LIMS, Trackwise databases (QTS), PDM and associated reporting tools; and the use of Excel for evaluation of data, is desirable.

+ Self-motivated and willing to learn new and changing responsibilities.


+ Familiar with auditing all elements of medical device quality management system requirements for key world geographies including the US FDA.

+ Familiar with auditing all elements of drug product/API quality management system requirements for key world geographies including the US FDA.

+ Highly compliance-oriented to ensure adherence to the principles of the applicable regulations and standards.

**Physical / Mental requirements**

+ Office environment, primarily.

+ Must be able to sit at a computer for extended periods of time.

**Non-Standard work schedule, travel or environment requirements**

+ Primarily, first shift. Extended work hours or weekend work may be required.

**Other job details**

+ Last day to apply: 5/24/2022

+ Employee Referral Bonus eligible

**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



Posted: 2022-05-11 Expires: 2022-06-10

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QO Specialist APRR

Kalamazoo, MI 49007

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