21 days old

Associate Stability Administration

Pfizer
Parsippany, NJ 07054
**ROLE SUMMARY**

Supports PGS and PGS customers in design and change management of applicable pharmaceutical stability programs; fields stability-related queries concerning marketed pharmaceutical products and active pharmaceutical ingredients; represents SLS Stability Administration on projects and teams internal and external to SLS; works with Customer Sites to ensure and reconcile that all stability commitments are met; prepares submission-ready stability commitments, protocols, and reports.



**ROLE RESPONSIBILITIES**



+ Acquires and demonstrates fundamental understanding of pharmaceutical stability and effective use of applicable computer applications and systems

+ Serves as single point-of-contact for stability-related questions on assigned products

+ Agile learner; acquires accounts and permissions for database access (e.g. PDOCS, LIMS, PLS, GDMS, PDM, etc.) and other information sources that relate to product stability and assembly, approval, and submission of regulatory stability reports and protocols

+ Accountable and reliable for timely, accurate and complete work

+ Designs and authors stability protocols and commitments

+ Supports LIMS change control; assures consistency between approved stability protocols and applicable SLS systems

+ Applies skills and discipline knowledge to on-time completion of assigned work; researches the necessary databases (e.g. LIMS) and other sources for information related to the stability report, protocol and commitment preparation and regulatory submission

+ Assists with gQTS investigations and change management activities

+ Supports creation and maintenance of controlled documents and records upon request

+ Performs regression analysis of stability data and recommends release limits where necessary

+ Communicates with customers to identify study requirements and convey pertinent information about data availability

+ Represents SLS Stability Administration on project teams

+ Proactively identifies and resolves problems; delivers creative solutions; contributes to SLS process and procedure improvements

+ Confidently supports regulatory and customer audits and inspections



**QUALIFICATIONS**



+ B.S. in a Science field is required; Chemistry, Biochemistry, Biology or similar technical degree is preferred

+ Minimum of 2-5 years of experience in the pharmaceutical industry is required

+ Aptitude for computerized systems required

+ Familiarity with GMPs and applicable regulations and guidelines (e.g. CFR, EMEA and ICH publications), and standard operating procedures is required

+ Strong communication (oral and written) and teamwork skills

+ Demonstrated critical thinking skills; close attention to detail and accuracy

+ Demonstrated ability to work both independently and in a team environment; able to receive coaching; self-motivated and willing to learn new and changing responsibilities

+ Flexibility to respond to constantly changing conditions and priorities

+ Demonstrated commitment to values-based leadership and achieving objectives in a manner that is supportive of Pfizer Values and Core Competencies



**PREFERRED QUALIFICATIONS**



+ Lab testing or site quality experience is preferred; experience with stability protocol and report authoring highly preferred

+ Knowledge of pharmaceutical stability operations and associated industry regulations including cGMP, 21 CFR, ICH, and other global regulations highly desired

+ Able to manage a heavy workload and short turn times with agility and optimism

+ High proficiency in Microsoft applications such as Word, Excel, Visio, Outlook, and PowerPoint

+ Working knowledge of Laboratory Information Management Systems (LIMS), including ability to pull data from LIMS

+ Deviation investigation and change management experience

+ Familiarity with document management systems (PDOCS/Documentum) and Quality Tracking Systems (gQTS/TrackWise) highly desired



**PHYSICAL/MENTAL REQUIREMENTS**

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



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

First shift, 40 hours per week. Work outside of standard hours and on weekends may be occasionally required.



**Other Job Details:**

Last Date to Apply for Job: December 1, 2020

Eligible for Employee Referral Bonus



**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

Categories

Posted: 2020-11-12 Expires: 2020-12-30

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Associate Stability Administration

Pfizer
Parsippany, NJ 07054

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