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Associate Specialist Quality O


Kalamazoo, MI
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Job Details


This posting is for a position on the QA DP team supporting Injectables and LSS with the primary responsibility of reviewing and approving Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's. Additional responsibilities will include lot release as well as deviation support. The QA DP team is a focused team whose responsibility is to ensure timely release of conforming Drug Product as well as timely completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA).


Grade 2 Primary Responsibilities Include:

+ Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's

+ Work with Operations to correct and reduce errors through effective communication and continuous improvement initiatives

+ Tracks and communicates status of tickets to Key Stakeholders

+ Generates COCs for certain Stopper and Solution EDPs and provides to end customer as appropriate

+ System Interface (LRT, LIMs, SAP, PacOne, QTS, PDOCs, etc...)

+ Audit support SME as neededGrade 2 Additional Responsibilities Include:

+ Conforming Lot Release for Finished Products (Level 1)

+ QASA Involvement

+ Right First Time/Zero Defect Projects

+ Deviation Support

+ Event Reports

+ QARs related to Ticket Review

+ Ticket Comments

+ Floor Support

+ Change Control ReviewIndependently, with minimal guidance, consistently produces quality work in one or more of the following: **Lot Release:** Evaluates data and releases Pfizer produced products that conform to corporate, customer, and regulatory standards. Maintains associated test plans. **Deviation Support:** Conducts and reviews non-conformance investigations. Provides guidance and oversight in identifying root cause and ensure appropriate CAPAs are implemented. The candidates will work with manufacturing and utilize tools such as Method 1, Human Error Reduction (HER), & Solution Tree in the course of the investigations. The candidates will also conduct Gemba meetings with the investigation teams. Leads and reviews formal risk assessments. Assigns release recommendations to implicated materials. **Change Control:** Evaluates and approves permanent changes to manufacturing and packaging equipment and processes, testing, IT systems and other GMP documents and programs. This includes change control that is internal to Kalamazoo, documented through the Quality Tracking System (QTS) and also changes that are controlled externally through the Product Change Report (PCP/PCR) system in collaboration with CMC.Maintains Quality Systems and ensures that products conform to regulatory, compendial and Pfizer Quality Standards.Participates in internal GMP audits and supports customer and regulatory audits.

Proven written and oral communication skills based on good Pfizer leader behaviors.


Education: BS in Chemistry, Microbiology, Engineering or other science related discipline

Experience Grade 2: No minimum experience required. At least 1 year of experience at a manufacturing site preferred.

**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.

**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.

**Last Date to Apply for Job:** 1/5/18

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.
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