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Sr. Product Professional Stability Administration


Kalamazoo, MI
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Job Details


This posting is for a Senior Professional position on the SLS Stability Administration team. The incumbent will be responsible for independently managing stability lifecycle (protocols, reports, change control) for assigned drug products and active pharmaceutical ingredients. The Sr. Professional will work on project teams for assigned products, ensuring all stability requirements are addressed, and may also represent the team on non-product specific projects both internal and external to SLS. The Sr. Professional will also have responsibilities to represent stability with SLS customer groups and serve as the contact for routine meetings with the customer sites.

Administration activities include ensuring that appropriate stability protocols are designed, written and executed to comply with applicable internal, US and Worldwide regulatory requirements. The role requires regular communication with customers to identify study requirements and convey pertinent information about data availability. The incumbent must have strong teamwork skills, demonstrate resourcefulness in locating and evaluating data and other pertinent information, and be accountable for the accuracy and completeness of the work. The role has responsibilities to interface with laboratory personnel, Quality Assurance and project teams both within SLS and across many PGS sites.


The incumbent

+ serves as single point-of-contact for stability lifecycle management on assigned products;

+ designs and authors protocols for stability studies, and oversees the LIMS study set-up and change control processes;

+ applies skills and discipline knowledge to contribute to the achievement of work; independently researches the necessary databases (e.g. LIMS) and other sources for information related to the stability performance of the product and assembles stability reports for regulatory submission;

+ performs regression analysis of stability data where necessary to support product needs;

+ communicates regularly with customers to identify study requirements, tracks timelines to ensure data are ready for submission and conveys pertinent information about data availability;

+ participates in or manages change control activities for stability changes;

+ performs peer review of other team members work; provides mentorship to peers and technicians as needed or assigned;

+ leads meetings and represents the group within SLS and QO on project teams as needed;

+ supports investigations, audits and regulatory queries.


B.S. Degree or higher in Chemistry or a related discipline.

Experience: minimum of 7 years of relevant experience in the pharmaceutical industry in a laboratory, stability or quality assurance role. This experience should include authoring technical documents for regulatory or quality assurance purposes. Preferred experience with regulatory affairs, regulatory changes, compliance documentation.

The candidate shall demonstrate these skills:

+ strong oral and written communication skills

+ critical thinking skills and attention to detail and accuracy

+ knowledge of GMPs and regulatory (e.g. ICH) guidelines

+ knowledge of statistics and regression analysis

+ mastery of core computer software/systems (Word, Excel, Internet Explorer, PDOCS etc.)

+ ability to work in a team environment and manage projects independently

Preferred skills include:

+ Working knowledge of LIMS

+ Familiarity with information systems such as GDMS, SAP and QTS.


The candidate shall be able to:

+ focus for long periods of time on detailed data and reports, with maintained attention to detail;

+ sit or potentially stand for long periods of time while working at the desk and computer

+ lift and move heavy binders and folders of paper

**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:** March 8, 2018

+ 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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