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Mgr. Customer Quality Assurance Specialist


Kalamazoo, MI
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Job Details


Primary quality contact for commercial and developmental Pfizer CentreOne (PC1) Quality representatives. Responsible for system set up, quality issues, concerns and communications as they pertain to the PC1 customer. This includes (at a minimum) notification for: investigations, change requests and regulatory audits. Participates in PC1 customer plant audits and drafting plant responses. Core team member for PC1 Customer developmental projects.

Present the plant quality systems to the customer during manufacturing, development activities, routine meetings, etc.

Review and evaluate sensitive and confidential information.


The initial primary responsibilities of this role will be to review current site Quality systems and evaluate necessary changes or updates to current practices or procedures in order to introduce PC1 customer products to the site. This includes at least the following: QTS, APRRs, SAP, LIMS, Quality Agreements, Communication practices, etc.

This role will transition to being the primary quality contact for commercial and developmental Pfizer CentreOne (PC1) Quality representatives as new products are introduced. The responsibilities will include the following:

Reviews documents for accuracy and ensure they meet quality documentation requirements for both Pfizer and the PC1 Customer. After the review, individual is the final Quality approver for the documentation. The documentation include: Exception reports, batch records, SOP's, Validation Reports, Technical Transfer Reports and Change Requests.

Prepare Quality Technical Agreements (QTAs) and revisions and coordinate changes, review and approvals with customer and Hospira. Coordinate change control process for QTAs.

Quality communication/notification to PC1 customer regarding; exception reports, audits, APRR, change control. Address follow up questions/clarification from customers.

Understand manufacturing process specific to assigned customers. Populate, report out and react to quality metrics for individual PC1 customers. Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Pfizer's standard processes and quality systems.

Participate in all meetings, site visits and audits specific to the assigned PC1 customers. Capture defined actions and track to completion. Act as the liaison between PC1 Customer and Plant Quality functions (Laboratories, Compliance, etc).

The most challenging aspect of the position will be understanding the customer dynamics and meeting their expectations while supporting the plant systems and processes.


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

Experience: Minimum 5 years pharmaceutical experience. Experience at a manufacturing site preferred.

Customer Quality Assurance Specialist must have the ability to effectively communicate through written and oral means. Understand the quality systems and be able to drive consistency between the PC1 customers and Pfizer. This person needs to understand the concepts incorporated in Quality Assurance in a GMP environment. Negotiation and problem solving skills are beneficial. Must be capable of multi- tasking job tasks through multiple customer and plant processes. Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, Access, Microsoft Project and Paradox) Experience working in a cross-functional, matrix environment.

Minimal travel, potentially up to 10%.

This role will interface with multiple levels of people within the organization, including Corporate management, PC1 customers, and plant personnel.

**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:** 4/6/18

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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